Kirkland Signature Minoxidil

Minoxidil


Costco Wholesale Company
Human Otc Drug
NDC 63981-380
Kirkland Signature Minoxidil also known as Minoxidil is a human otc drug labeled by 'Costco Wholesale Company'. National Drug Code (NDC) number for Kirkland Signature Minoxidil is 63981-380. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Kirkland Signature Minoxidil drug includes Minoxidil - 5 g/100mL . The currest status of Kirkland Signature Minoxidil drug is Active.

Drug Information:

Drug NDC: 63981-380
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Kirkland Signature Minoxidil
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Minoxidil
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Costco Wholesale Company
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:MINOXIDIL - 5 g/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 25 Aug, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA075598
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Costco Wholesale Company
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:311724
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000175379
N0000175564
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:5965120SH1
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Arteriolar Vasodilator [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Arteriolar Vasodilation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:Arteriolar Vasodilation [PE]
Arteriolar Vasodilator [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63981-380-406 BOTTLE in 1 CARTON (63981-380-40) / 60 mL in 1 BOTTLE (63981-380-16)25 Aug, 2013N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose hair regrowth treatment for men

Product Elements:

Kirkland signature minoxidil minoxidil minoxidil minoxidil alcohol propylene glycol water

Indications and Usage:

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings:

Warnings for external use only. for use by men only. flammable: keep away from fire or flame do not use if • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your hair loss • you are under 18 years of age. do not use on babies and children. • your scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp ask a doctor before use if you have heart disease when using this product • do not apply on other parts of the body • avoid contact with the eyes. in case of accidental contact, rinse eyes with large amounts of cool tap water. • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. results may occ
ur at 2 months with twice a day usage. for some men, you may need to use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person. this product will not work for all men. stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months may be harmful if used when pregnant or breast-feeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)

Do Not Use:

Warnings for external use only. for use by men only. flammable: keep away from fire or flame do not use if • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your hair loss • you are under 18 years of age. do not use on babies and children. • your scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp ask a doctor before use if you have heart disease when using this product • do not apply on other parts of the body • avoid contact with the eyes. in case of accidental contact, rinse eyes with large amounts of cool tap water. • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. results may occur at 2 months with twice a day usage. for some men, you may need to use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person. this product will not work for all men. stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months may be harmful if used when pregnant or breast-feeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)

When Using:

When using this product • do not apply on other parts of the body • avoid contact with the eyes. in case of accidental contact, rinse eyes with large amounts of cool tap water. • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. results may occur at 2 months with twice a day usage. for some men, you may need to use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person. this product will not work for all men.

Dosage and Administration:

Directions • apply one ml with dropper 2 times a day directly onto the scalp in the hair loss area • using more or more often will not improve results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Stop Use:

Stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months

Package Label Principal Display Panel:

Principal display panel kirkland signature compare to men’s rogaine ® extra strength active ingredient #1 dermatologist recommended active ingredient extra strength for men minoxidil topical solution usp, 5% hair regrowth treatment unscented clinically proven to help regrow hair reactivates hair follicles to stimulate regrowth topical solution 6 month supply not for use by women 6 x 60 ml (2 fl oz) bottles total 360 ml (12 fl oz) minoxidil topical solution usp, 5% carton image 1 minoxidil topical solution usp, 5% carton image 2

Further Questions:

Questions or comments? 1-800-719-9260 consumer information important information about minoxidil topical solution usp 5% hair regrowth treatment unscented extra strength for men • clinically proven to help regrow hair • reactivates hair follicles to stimulate regrowth • provides more hair regrowth than minoxidil topical solution 2% not for use by women save this leaflet for future reference it takes time to regrow hair. results may occur at 2 months with twice a day usage. for some men, you may need to use this product for at least 4 months before you see results. please read this leaflet carefully. it will help you understand how to use minoxidil topical solution 5% and what to expect from its use. if you have any questions after reading this leaflet, or anytime while using minoxidil topical solution 5%, you should ask your healthcare professional or call us at 1-800-719-9260. what is minoxidil topical solution 5%? minoxidil topical solution 5% is a colorless liquid medication containing 5% minoxidil for use only on the scalp to help regrow hair in men. who may use minoxidil topical solution 5%? minoxidil topical solution 5% is for use only by men. minoxidil topical solution 5% may be appropriate for you if you are a male at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the scalp (vertex only, as shown below). it is not intended for frontal baldness or a receding hairline. the common inherited thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss. minoxidil topical solution 5% is for men with hair loss or thinning hair that begins on the vertex of the scalp. minoxidil topical solution 5% is more likely to regrow hair in men with hair loss in the range shown below. if men have more hair loss than shown, minoxidil topical solution 5% may not work. many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. if you have no family history of gradual thinning hair or of gradual hair loss, or your hair loss is patchy, see your doctor. who should not use minoxidil topical solution 5%? • women should not use minoxidil topical solution 5% because studies have shown it works no better in women than minoxidil topical solution 2%. some women may also grow facial hair. in addition, minoxidil topical solution 5% may be harmful if used during pregnancy or breast-feeding. • minoxidil topical solution 5% should not be used on babies or for children under 18 years old. • minoxidil topical solution 5% will not prevent or improve hair loss which may occur with the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; too much vitamin a intake), low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. also, minoxidil topical solution 5% will not improve hair loss due to: • damage from the use of hair care products which cause scarring or deep burns of the scalp. • hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp. do not use if you are not sure of the reason for your hair loss. will minoxidil topical solution 5% work for me? the amount of hair regrowth is different for each person. not everyone will respond to minoxidil topical solution 5%. the response to minoxidil topical solution 5% cannot be predicted. it is unlikely anyone will be able to grow back all their hair. however, to see your best results with minoxidil topical solution 5%, make sure you get the medicine directly to the scalp and apply it twice a day, every day. you may get better results if you have been losing your hair for a short period of time or have little hair loss. however, for some men minoxidil topical solution 5% may not work. how soon can i expect results from using minoxidil topical solution 5%? since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with minoxidil topical solution 5% also takes time. results may be seen as early as 2 months with twice daily use. for some men, it may take at least 4 months for results to be seen. if you do not see any results after 4 months, stop using minoxidil topical solution 5%. when you first begin to use minoxidil topical solution 5%, your hair loss may increase temporarily for up to 2 weeks. this is likely a sign that you are getting rid of old hairs in order to regrow more new hairs. this temporary increase in hair loss is expected and is a part of the process for how minoxidil topical solution 5% regrows hair. remember, this increased hair loss is temporary. however, if it continues after two weeks, see your doctor. if minoxidil topical solution 5% is working, what will the hair look like? at first, hair growth is usually soft, downy, colorless hairs (like peach fuzz). after further use, the new hairs should be the same color and thickness as the other hairs on your scalp. how long do i need to use minoxidil topical solution 5%? if you experience hair regrowth, continued use of minoxidil topical solution 5% is necessary or the hair loss will begin again. in studies with minoxidil topical solution 5%, hair regrowth has not been shown to last longer than 48 weeks of continuous treatment in large clinical trials. what happens if i completely stop using minoxidil topical solution 5%? will i keep the new hair? continuous use of minoxidil topical solution 5% is needed to maintain hair regrowth. if you stop using minoxidil topical solution 5%, you will lose your newly regrown hair in 3 to 4 months. how do i use minoxidil topical solution 5%? for best results, apply 1 ml with applicator 2 times a day directly onto the scalp in the hair loss area. using more or using more often will not improve results. each bottle should last one month, if used as directed. allow time for minoxidil topical solution 5% to dry completely before wearing a hat, or lying on a pillow, etc. minoxidil topical solution 5% may cause staining of clothing or linens if damp on the scalp. when applying minoxidil topical solution 5% at night, be sure to allow 2 to 4 hours to dry completely. never take this product by mouth or apply to other parts of the body. when do i use minoxidil topical solution 5%? apply minoxidil topical solution 5% once in the morning and once at night. the nighttime application should occur 2 to 4 hours before going to bed to allow for drying. each bottle should last one month, if used as directed. what if i miss a dose or forget to use minoxidil topical solution 5%? if you miss one or two daily doses of minoxidil topical solution 5%, just continue with your next dose. you should not make up for missed doses. can i use minoxidil topical solution 5% more than twice a day? will it work faster, better? no. minoxidil topical solution 5% will not work faster or better if used more than two times a day. studies have been carefully conducted to determine the correct amount of minoxidil topical solution 5% needed to get the best results. more frequent use or larger doses have not been shown to speed up hair growth and may increase your chance of side effects. what kind of shampoo should i use with minoxidil topical solution 5%? if you wash your scalp before applying minoxidil topical solution 5%, use a mild shampoo. can i use hair sprays, mousses, conditioners, gels, etc.? yes. hair sprays, spritz, or styling aids may be used on your hair while using minoxidil topical solution 5%. for best results, minoxidil topical solution 5% should be allowed to soak into the scalp before using any styling products. try to develop a good routine of applying minoxidil topical solution 5% first, and then applying styling products and style as usual. keep in mind that your best results will be seen with proper application. can i have my hair colored or permed or use hair relaxers while using minoxidil topical solution 5%? yes. we have no evidence that coloring or perming your hair or that the use of relaxers change the effect of minoxidil topical solution 5%. however, because the use of a permanent wave and hair color can cause scalp irritation on certain people, we recommend the following precautions: 1) to avoid possible scalp irritation, you should make sure all of the minoxidil topical solution 5% has been washed off the hair and scalp before using color or perm chemicals. 2) for best results, do not apply minoxidil topical solution 5% on the same day that you use a chemical treatment on your hair. 3) do not use minoxidil topical solution 5% for 24 hours after using any chemicals to make sure your scalp has not been irritated by the perm or color treatment. if no irritation occurs, continue use of minoxidil topical solution 5% as usual. 4) simply restart your normal minoxidil topical solution 5% routine. there is no need to use more minoxidil topical solution 5% to make up for missed applications. missing one day of minoxidil topical solution 5% will not affect your hair regrowth results. can i apply minoxidil topical solution 5% and wash my hair an hour later? no. for minoxidil topical solution 5% to work best, you should allow it to stay on the scalp for about 4 hours before washing. directions for use 1) remove the cap. to remove, push down and turn in direction of the arrows on the cap. 2) part your hair in the area of hair thinning/loss. follow the instructions below for using the dropper applicator and apply one ml 2 times a day directly onto the scalp in the hair loss area. do not use more. spread the liquid evenly over the hair loss area. if you use your fingers, wash hands with soap and water immediately. each bottle should last about one month, if used as directed. use a mild shampoo if you wash your scalp before applying minoxidil topical solution 5%. using the dropper applicator 1) squeeze the rubber bulb and insert the dropper into the bottle. release the bulb, allowing the dropper to fill to the 1 ml line. if the level of the solution is above the 1 ml line, squeeze the extra amount back into the bottle. 2) next, place the tip of the dropper near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. to prevent the solution from running off the scalp, apply a small amount at a time. 3) after each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed. warnings for external use only for use by men only flammable: keep away from fire or flame do not use if • you are a woman • your amount of hair loss is different than that shown on the other side of this leaflet or your hair loss is on the front of the scalp. minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your hair loss • you are under 18 years of age. do not use on babies and children. • scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp ask a doctor before use if you have heart disease. when using this product • do not apply on other parts of the body • avoid contact with the eyes. in case of accidental contact, rinse eyes with large amounts of cool tap water. • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. results may occur at 2 months with twice a day usage. for some men, you may need to use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person. this product will not work for all men. stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months may be harmful if used when pregnant or breast-feeding. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222) what are the most common side effects with minoxidil topical solution 5%? the most common side effects are itching and skin irritation of the treated area of the scalp. if scalp irritation continues, stop use and see a doctor. minoxidil topical solution 5% contains alcohol, which will cause burning or irritation of the eyes. if minoxidil topical solution 5% accidentally gets into eyes, rinse with large amounts of cool tap water. can minoxidil topical solution 5% produce unwanted hair growth? unwanted hair growth on the face and other parts of the body has been reported in women. but it is rare and reversible. if you develop unwanted hair, stop using minoxidil topical solution 5%. over time, the unwanted hair, if caused by minoxidil topical solution 5%, will go away. you can take the following steps to decrease the chances of unwanted hair growth: 1) limit the application of minoxidil topical solution 5% only to the scalp; 2) if you use your hands to apply minoxidil topical solution 5%, wash your hands well immediately afterwards; and 3) after your nighttime application of minoxidil topical solution 5%, allow enough drying time before going to bed (usually 2 to 4 hours). can i use minoxidil topical solution 5% for baldness or hair loss in babies or children? no. minoxidil topical solution 5% must not be used to treat baldness or hair loss in babies and children. if you have any other questions, ask your healthcare professional or call us at 1-800-719-9260. store at 20º to 25ºc (68º to 77ºf). keep tightly closed. made in canada packaged by perrigo® allegan, mi 49010 rev 05-14 : 38000 00 j4 vertex image dropper bottle image


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