2. Drugs
  3. Human OTC Drug
  4. Cortizone 10 Cooling Relief

Cortizone 10 Cooling Relief

Hydrocortisone


Chattem, Inc.
Human Otc Drug
NDC 41167-0036
Cortizone 10 Cooling Relief also known as Hydrocortisone is a human otc drug labeled by 'Chattem, Inc.'. National Drug Code (NDC) number for Cortizone 10 Cooling Relief is 41167-0036. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Cortizone 10 Cooling Relief drug includes Hydrocortisone - 10 mg/g . The currest status of Cortizone 10 Cooling Relief drug is Active.

Drug Information:

Drug NDC: 41167-0036
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: Cortizone 10 Cooling Relief
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: Hydrocortisone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Chattem, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
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:HYDROCORTISONE - 10 mg/g
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: OTC MONOGRAPH NOT FINAL
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: 01 Oct, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 23 Dec, 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: part348
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:Chattem, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:106258
198706
203105
206314
206352
846161
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:N0000175576
N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:WI4X0X7BPJ
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 MOA:Corticosteroid Hormone Receptor Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Corticosteroid [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:Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
41167-0036-01 TUBE in 1 CARTON (41167-0036-0) / 28 g in 1 TUBE01 Oct, 2008N/ANo
41167-0036-11 TUBE in 1 CARTON (41167-0036-1) / 35 g in 1 TUBE01 Oct, 2008N/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.
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Purpose:

Purpose anti-itch

Purpose anti-itch

Purpose anti-itch

Purpose anti-itch

Purpose anti-itch

Product Elements:

Cortizone 10 cooling relief hydrocortisone hydrocortisone hydrocortisone aloe vera leaf dimethicone edetate disodium glycerin maltodextrin methylparaben polysorbate 60 propylparaben sodium citrate water cyclomethicone 5 alcohol cortizone 10 hydrocortisone hydrocortisone hydrocortisone aloe vera leaf aluminum sulfate yellow wax calcium acetate cetostearyl alcohol glycerin maltodextrin methylparaben mineral oil petrolatum propylparaben sodium cetostearyl sulfate sodium lauryl sulfate water cortizone 10 intensive healing hydrocortisone hydrocortisone hydrocortisone water glycerin dimethicone petrolatum cetyl alcohol aloe vera leaf stearyl alcohol cetostearyl alcohol polysorbate 60 vitamin a palmitate glyceryl monostearate edetic acid potassium hydroxide diazolidinyl urea benzyl alcohol methylparaben butylated hydroxytoluene propylparaben alpha-tocopherol acetate cortizone 10 hydrocortisone hydrocortisone hydrocortisone petrolatum cortizone 10 plus hydrocortisone hydrocortisone hydrocortisone aloe vera leaf aluminum sulfate yellow wax calcium acetate cetostearyl alcohol cholecalciferol glycerin isopropyl palmitate maltodextrin methylparaben mineral oil petrolatum propylene glycol propylparaben vitamin a palmitate sodium cetostearyl sulfate sodium lauryl sulfate alpha-tocopherol acetate water corn oil

Indications and Usage:

Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor

Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor

Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor

Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor

Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor

Warnings:

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only do not use in the genital area if you have a vaginal discharge. consult a doctor. for the treatment of diaper rash. consult a doctor. when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

When Using:

When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator

When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator

When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator

When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator

When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator

Dosage and Administration:

Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs

Package Label Principal Display Panel:

Principal display panel cooling gel formula itch relief cools itch fast relief that lasts sunburn poison ivy insect bites inflammation and r edness cools itch on contact maximum strength cortizone-10® c ooling r elief gel net wt 1oz (28g) 1% hydrocortisone anti-itch gel principal display panel cooling gel formula itch relief cools itch fast relief that lasts • sunburn • poison ivy • insect bites inflammation and redness cools itch on contact maximum strength cortizone-10® cooling relief gel net wt 1oz (28g) 1% hydrocortisone anti-itch gel

Principal display panel 10 nourishing ingredients itch relief fast itch lasts 10 hours eczema sunburn dry, itchy skin inflammation & redness hydrates irritated, itchy skin plus ultra moisturizing maximum strength cortizone-10 ® net wt 1oz (28g) 1% hydrocortisone anti-itch creme principal display panel 10 nourishing ingredients itch relief fast itch lasts 10 hours • eczema • sunburn • dry, itchy skin inflammation & redness hydrates irritated, itchy skin plus ultra moisturizing maximum strength cortizone-10® net wt 1oz (28g) 1% hydrocortisone anti-itch creme

Principal display panel fast itch relief lasts 10 hours 24 hours moisturizing itch relief eczema psoriasis itchy skin inflammation & redness extra creamy formula, gentle on skin intensive healing formula † maximum strength cortizone-10 ® net wt 1oz (28g) 1% hydrocortisone anti-itch crème principal display panel fast itch relief lasts 10 hours 24 hours moisturizing itch relief • eczema • psoriasis • itchy skin inflammation & redness extra creamy formula, gentle on skin intensive healing formula† maximum strength cortizone-10® net wt 1oz (28g) 1% hydrocortisone anti-itch crème

Principal display panel fast itch relief last 10 hours water resistant formula itch relief psoriasis poison ivy irritation & rashes inflammation & redness locks in moisture anti – itch ointment helps seal in healing doctors #1 itch medicine* tm recommend the itch medicine doctors recommend* maximum strength cortizone-10 ® net wt 1oz (28g) 1% hydrocortisone anti-itch ointment principal display panel fast itch relief last 10 hours water resistant formula itch relief • psoriasis • poison ivy • irritation & rashes inflammation & redness locks in moisture anti – itch ointment helps seal in healing doctors #1 itch medicine*tm recommend the itch medicine doctors recommend* maximum strength cortizone-10® net wt 1oz (28g) 1% hydrocortisone anti-itch ointment

Principal display panel fast itch relief last 10 hours calming aloe vera itch relief psoriasis poison ivy insect bites inflammation & redness soothes itch, irritation & rashes doctors #1 itch medicine* tm recommend maximum strength cortizone-10 ® plus net wt 1oz (28g) 1% hydrocortisone anti-itch creme principal display panel fast itch relief last 10 hours calming aloe vera itch relief • psoriasis • poison ivy • insect bites inflammation & redness soothes itch, irritation & rashes doctors #1 itch medicine*tm recommend maximum strength cortizone-10® plus net wt 1oz (28g) 1% hydrocortisone anti-itch creme


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.

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