Label: ACNE FIGHTING OIL-FREE FACIAL WIPES- salicylic acid cloth

  • 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 April 22, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1.0%

  • Purpose

    Acne Treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    Avoid contact with the eyes. 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

    • clean the skin by wiping the entire affected area one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

  • Inactive ingredients

    Water (Aqua), Glycerin, Betaine, Solanum Lycopersicum (Tomato) Fruit Extract, Aspalathus Linearis (Red Tea) Leaf Extract, Polyglyceryl-4 Caprate, Caprylyl/Capryl Glucoside, Hamamelis Virginiana (Witch Hazel) Extract, Citrullus Vulgaris (Watermelon) Fruit Extract, Capiscum Frutescens (Red Pepper) Fruit Extract, Galactoarabinan, Alcohol, Citric Acid, Sodium Hydroxide, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Fragrance (Parfum).

  • Questions?

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  • PRINCIPAL DISPLAY PANEL - 40 Facial Wipe Packet

    NATURAL
    ACNE
    FIGHTING

    NATURAL
    95%
    INGREDIENTS

    40 ACNE FIGHTING
    OIL-FREE FACIAL WIPES

    PRINCIPAL DISPLAY PANEL - 40 Facial Wipe Packet
  • INGREDIENTS AND APPEARANCE
    ACNE FIGHTING OIL-FREE FACIAL WIPES 
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69840-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid10 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BETAINE (UNII: 3SCV180C9W)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)  
    WATERMELON (UNII: 231473QB6R)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    TABASCO PEPPER (UNII: J1M3NA843L)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69840-016-0740 in 1 PACKET; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2019
    Labeler - Yes To Inc. (788689680)
    Establishment
    NameAddressID/FEIBusiness Operations
    Albaad USA Inc.143406457MANUFACTURE(69840-016)
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