Label: ALUMIER MD ACNE BALANCING SERUM- salicylic acid cream
- NDC Code(s): 69473-002-01
- Packager: Alumier Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 2, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
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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.
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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
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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.
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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 creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69473-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLIC ACID (UNII: OBL58JN025) HYALURONATE SODIUM (UNII: YSE9PPT4TH) RESVERATROL (UNII: Q369O8926L) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) TRICAPRYLIN (UNII: 6P92858988) XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) PROPANEDIOL (UNII: 5965N8W85T) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OLIGOPEPTIDE-10 (UNII: Q46328TRNK) HONEY (UNII: Y9H1V576FH) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERYL CAPRATE (UNII: 197M6VFC1W) PENTYLENE GLYCOL (UNII: 50C1307PZG) SODIUM HYDROXIDE (UNII: 55X04QC32I) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) RICE BRAN (UNII: R60QEP13IC) .BETA.-THUJAPLICIN (UNII: U5335D6EBI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69473-002-01 1 in 1 CARTON 07/01/2019 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2019 Labeler - Alumier Labs (079603173)