Active Ingredient
Salicylic Acid 2.0%
Alumier Md Acne Balancing Serum Cream
FDA Label NDC 69473-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alumier Labs for the product Alumier Md Acne Balancing Serum (NDC 69473-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne treatment
Use
- for the treatment of acne
Warnings
- For external use only.
Otc - When Using
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.
Otc - Stop Use
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
- for more severe cases, and/or if improvement is not apparent within 6-8 weeks, consult a health care professional
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.
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
- 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
For New Users
Other Information
- Do not use if security seal is broken or missing
- You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 550 Cochituate Road, Suite 25, Framingham, MA 01701
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
Alumier MD
Acne Balancing Serum
ACNE TREATMENT
WITH 2% SALICYLIC ACID
NPN: 80063862
30 mL/1 fl oz
* Please review the disclaimer below.
