Label: ALUMIER MD HYDRASMOOTH NON-COMEDOGENIC MOISTURIZER- salicylic acid cream

  • NDC Code(s): 69473-003-01, 69473-003-02
  • Packager: Alumier Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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  • Drug Facts

  • Active Ingredient

    Salicylic Acid 1.0%

  • 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

    Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

  • Directions

    • for adults 18 years and older
    • cleanse skin thoroughly before applying the product

    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

    • Store in a cool, dry place at room temperature
    • 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, Propanediol, Caprylyl Methicone, Dimethicone, Caprylic/Capric Triglyceride, Butylene Glycol, Glycerin, Cetearyl Alcohol, Cocamidopropyl Dimethylamine, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glyceryl Stearate, Sucrose Stearate, Aloe Barbadensis Leaf Juice, Hinokitiol, Poria Cocos Extract, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa Bran Extract, Resveratrol, Allantoin, Oligopeptide-10, Spiraea Ulmaria Extract, Tocopheryl Acetate, Sodium Hyaluronate, Polysilicone-11, Polymethyl Methacrylate, Adipic Acid/Diglycol Crosspolymer, Tricaprylin, Caprylyl Glycol, Xanthan Gum, Caprylic Acid, Sorbitan Stearate, Sodium Hydroxide, Disodium EDTA, Tocopherol, Xylitol, Citric Acid, Ethylhexylglycerin.

  • Company Information

    ALUMIER EUROPE LTD.

    VISION EXCHANGE BUILDING

    TERRITORIALS STREET

    ZONE 1, CENTRAL BUSINESS DISTRICT

    BIRKIRKARA CBD 1070, MALTA

    WWW.ALUMIERMD.COM

    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

    1

  • INGREDIENTS AND APPEARANCE
    ALUMIER MD HYDRASMOOTH NON-COMEDOGENIC MOISTURIZER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    FU LING (UNII: XH37TWY5O4)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    RESVERATROL (UNII: Q369O8926L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HONEY (UNII: Y9H1V576FH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
    RICE BRAN (UNII: R60QEP13IC)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRICAPRYLIN (UNII: 6P92858988)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-003-011 in 1 CARTON07/01/201912/01/2023
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:69473-003-021 in 1 CARTON12/01/2023
    250 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/01/2019
    Labeler - Alumier Labs (079603173)
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