Label: ALUMIER MD ACNE BALANCING SERUM- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

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

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne treatment

  • Use

    • for the treatment of acne
  • 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.

    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

    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

    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

    • 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

    acne balancing serum

  • INGREDIENTS AND APPEARANCE
    ALUMIER MD ACNE BALANCING SERUM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-002-011 in 1 CARTON07/01/2019
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2019
    Labeler - Alumier Labs (079603173)
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