Label: ACNEFREE DERMATOLOGY INSPIRED CARE BLACKHEAD REMOVING SCRUB ACNE TREATMENT- 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 July 1, 2021

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  • Active ingredient

    Salicylic acid 2%

  • Uses

    For the treatment of acne

  • Warnings

    For external use only

  • When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

  • Inactive ingredients

    cocus nucifera (coconut) oil, purified water, sodium hydroxide, glycine soja, aloe barbadensis leaf extract, olive oil, citrus sinesis oil, glycerin, sodium lactate, sodium glucconate, fragrance, CI 77492, CI 77891, kaolin clay and disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    ACNEFREE DERMATOLOGY INSPIRED CARE BLACKHEAD REMOVING SCRUB ACNE TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79061-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79061-259-0150 mL in 1 TUBE; Type 0: Not a Combination Product07/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/31/2018
    Labeler - Relumins Labs LLC (081506626)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMESTHETIC LABS. CORP.725862577MANUFACTURE(79061-259)
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