Alumier Md Post Procedure Kit With Hydrocortisone
Titanium Dioxide, Zinc Oxide, Hydrocortisone
Alumier Labs
Human Otc Drug
NDC 69473-018Alumier Md Post Procedure Kit With Hydrocortisone also known as Titanium Dioxide, Zinc Oxide, Hydrocortisone is a human otc drug labeled by 'Alumier Labs'. National Drug Code (NDC) number for Alumier Md Post Procedure Kit With Hydrocortisone is 69473-018. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Alumier Md Post Procedure Kit With Hydrocortisone drug includes . The currest status of Alumier Md Post Procedure Kit With Hydrocortisone drug is Active.
Drug Information:
| Drug NDC: | 69473-018 |
| 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: | Alumier Md Post Procedure Kit With Hydrocortisone |
| 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: | Titanium Dioxide, Zinc Oxide, Hydrocortisone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alumier Labs |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| 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: | 22 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| 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: | part352 |
| 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: | Alumier Labs
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106258
|
| 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. |
| UNII: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69473-018-01 | 1 KIT in 1 CARTON (69473-018-01) * 15 mL in 1 TUBE (69473-017-02) * 15 mL in 1 TUBE * 15 mL in 1 TUBE (69473-006-04) | 22 Mar, 2022 | N/A | No |
| 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 anti-itch cream
Purpose sunscreen
Product Elements:
Alumier md post procedure kit with hydrocortisone titanium dioxide, zinc oxide, hydrocortisone alumier md sheer hydration titanium dioxide, zinc oxide lecithin, soybean polyhydroxystearic acid (2300 mw) zinc oxide zinc oxide titanium dioxide titanium dioxide triethoxycaprylylsilane water glyceryl monostearate acacia polyoxyl 20 cetostearyl ether hydroxyethyl behenamidopropyl dimonium chloride magnesium ascorbyl phosphate ascorbic acid c20-40 pareth-10 butyloctyl salicylate glycerin vitis vinifera seed aluminum monostearate medium-chain triglycerides xanthan gum alkyl (c12-15) benzoate propanediol carboxymethylcellulose sodium, unspecified form .alpha.-tocopherol acetate edetate disodium edetic acid cetostearyl alcohol peg-100 stearate aluminum oxide glutathione microcrystalline cellulose phenoxyethanol resveratrol ethylhexylglycerin synthetic wax (1800 mw) alumier md intensive recovery hydrocortisone honey eucalyptus globulus leaf aloe vera leaf tricaprylin aspalathus linearis whole .beta.-thujaplicin lavandula angustifolia flowering top chamaemelum nobile flower pseudopterogorgia elisabethae apple green tea leaf cranberry squalane ethylhexylglycerin hydrocortisone hydrocortisone jojoba oil docosanol xanthan gum water shea butter medium-chain triglycerides lecithin, soybean dimethicone propanediol sodium methyl stearoyl taurate niacinamide resveratrol indian frankincense caprylyl glycol pentylene glycol mentha spicata poly(methyl methacrylate; 450000 mw) sodium hydroxide cocoa butter caprylic acid hydrogenated soybean lecithin edetate disodium edetic acid prezatide copper rosemary xylitol glycerin alumier md sensicalm medium-chain triglycerides cetyl alcohol niacinamide allantoin .alpha.-tocopherol acetate p-anisic acid xanthan gum sodium hydroxide caprylyl/capryl oligoglucoside xylitol caprylic acid 4-terpineol, (+/-)- edetate sodium edetic acid edetate disodium edetic acid water glycerin propanediol cocamidopropyl hydroxysultaine sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) aloe vera leaf yucca schidigera root sunflower oil linalyl acetate .beta.-ocimene, (3z)- disodium cocoyl glutamate caprylyl glycol linalool, (+/-)- sodium chloride sorbitan monooleate ceramide ng
Indications and Usage:
Uses adults and children 2 years of age and older: for the temporary relief of minor skin irritations, rashes, itching and redness due to eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (e.g. caused by soaps, detergents, cosmetics and/or jewelry), seborrheic dermatitis, psoriasis.
Use helps prevent sunburn
Warnings:
Warnings for external use only do not use for the treatment of diaper rash, except on the advise of a physician when using this product avoid contact with eyes, do not use in or around the eyes stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. do not begin use of any other hydrocortisone product unless directed by a physician. keep out of reach of children . if swallowed, call a poison control centre or get medical help right away.
Warnings for external use only when using this product do not use on damaged or broken skin keep out of eyes. rinse with water to remove. stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing keep out of reach of children . if swallowed, call a poison control centre or get medical help right away.
Do Not Use:
Warnings for external use only do not use for the treatment of diaper rash, except on the advise of a physician when using this product avoid contact with eyes, do not use in or around the eyes stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. do not begin use of any other hydrocortisone product unless directed by a physician. keep out of reach of children . if swallowed, call a poison control centre or get medical help right away.
Warnings for external use only when using this product do not use on damaged or broken skin keep out of eyes. rinse with water to remove. stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing keep out of reach of children . if swallowed, call a poison control centre or get medical help right away.
When Using:
When using this product avoid contact with eyes, do not use in or around the eyes
When using this product do not use on damaged or broken skin keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions adults and children 2 years of age and older, apply sparingly to affected area not more than three to four times daily do not use on children under 2 years of age, consult a physician
Directions apply liberally/generously (and evenly) 15 minutes before sun exposure reapply at least every 2 hours sun protection measures : spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher and other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeved shirts, pants, hats and sunglasses use a water resistant sunscreen if swimming or sweating
Stop Use:
Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. do not begin use of any other hydrocortisone product unless directed by a physician.
Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing
Package Label Principal Display Panel:
Product packaging inside box box