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NDC 69473-0002-01 Alumier MD Acne Balancing Serum 20 mg/mL Details
Alumier MD Acne Balancing Serum 20 mg/mL
Alumier MD Acne Balancing Serum is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Alumier Labs. The primary component is SALICYLIC ACID.
MedlinePlus Drug Summary
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.
Related Packages: 69473-0002-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical
Product Information
| NDC | 69473-0002 |
|---|---|
| Product ID | 69473-002_87eb6adc-c38f-d7df-e053-2a95a90aa747 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Alumier MD Acne Balancing Serum |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Salicylic Acid |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | SALICYLIC ACID |
| Labeler Name | Alumier Labs |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333D |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69473-0002-01 (69473000201)
| NDC Package Code | 69473-002-01 |
|---|---|
| Billing NDC | 69473000201 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (69473-002-01) / 30 mL in 1 BOTTLE, PUMP |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 87eb6adc-c38e-d7df-e053-2a95a90aa747 Details
Warnings
- For external use only.
When using this product
- avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- skin irritation and dryness is more likely to occur if you use another topical acne product at the same time. If irritation occurs, only use one topical acne product at a time.
Directions
- cleanse skin thoroughly before applying the product
- cover the entire affected area with a thin layer one to three times daily or as directed by a health care practitioner
- if dryness or peeling occurs, reduce application to once a day or every other day
For New Users
- apply product to a small area once a day for three days to test if you are sensitive to this product
- if no discomfort occurs, cover the entire affected area with a thin layer
- start with one application daily, then gradually increase to two to three times daily, if needed
- if dryness or peeling occurs, reduce application to once a day or every other day
Other information
Inactive Ingredients
Water/Aqua/Eau, Dimethyl Isosorbide, Propanediol, Niacinamide, Glyceryl Caprate, Hinokitiol, Sea Whip Extract, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Gum Extract, Aloe Barbadensis Leaf Juice, Caprylic Acid, Caprylyl Glycol, Sodium Hyaluronate, Glycerin, Resveratrol, Oligopeptide-10, Honey Extract (Extrait de Miel), Allantoin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allyl Methacrylates Crosspolymer, Xanthan Gum, Cetyl Hydroxyethylcellulose, Pentylene Glycol, Disodium EDTA, Polymethyl Methacrylate, Tricaprylin, Sodium Hydroxide, Xylitol, Ethylhexylglycerin.
Company Information
ALUMIER EUROPE LTD.
5 ST. FREDERICK STREET
VALLETTA VLT 1470, MALTA
WWW.ALUMIERMD.COM
EUROPE • UNITED STATES • CANADA
UNITED KINGDOM
DISTRIBUTED IN CANADA BY
ALUMIER LABS INC.,
436 LIMESTONE CRESCENT
TORONTO, ON, M3J 2S4
DISTRIBUTED IN THE USA BY
ALUMIER LABS INC.,
550 COCHITUATE ROAD, SUITE 25
FRAMINGHAM, MA 01701
MANUFACTURED IN CANADA UNDER
LICENSE FROM ALUMIER EUROPE LTD.
Product Packaging
INGREDIENTS AND APPEARANCE
| ALUMIER MD ACNE BALANCING SERUM
salicylic acid cream |
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| Labeler - Alumier Labs (079603173) |