Label: ALUMIER MD ACNE CLARIFYING CLEANSER- salicylic acid gel

  • 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 March 8, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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, call a Poison Control Centre or get medical help right away.

  • Directions

    • use twice daily, in the morning and evening
    • moisten face with lukewarm water
    • pump a small amount into your hand
    • add water and apply to your face and neck, massaging in a circular motion
    • rinse thoroughly with lukewarm water and gently pat dry

    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, Sodium C14-16 Olefin Sulfonate, Propanediol, Dimethyl Lauramide/Myristamide, Glycerin, Cocamidopropyl Dimethylamine, Cocamidopropyl Hydroxysultaine, Glyceryl Caprate, Lauryl Lactyl Lactate, Oligopeptide-10, Aloe Barbadensis Leaf Juice, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa (Rice) Bran Extract, Carbomer, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Caprylic Acid, 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 Clarifying Cleanser

    ACNE TREATMENT WITH 2%

    SALICYLIC ACID

    NPN: 80064465

    177 mL/6 fl oz

    acne clarifying cleanser rev

  • INGREDIENTS AND APPEARANCE
    ALUMIER MD ACNE CLARIFYING CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-001
    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
    CAPRYLIC ACID (UNII: OBL58JN025)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    HONEY (UNII: Y9H1V576FH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICE BRAN (UNII: R60QEP13IC)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-001-011 in 1 CARTON07/01/2019
    1177 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!