Label: SALICYLACNE-1% CLEARING GEL- 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 June 17, 2021

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  • Active Ingredients

    Salicylic Acid 1%

  • Purpose

    Acne Treatment

  • Uses

    Use for treatment of acne

  • Warning

    For external use only

  • Do not use

    Allergy alert: Do not use this product if you have a known allergy to salicylic acid

  • When using this product

    Skin irritation and dryness is more likely occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • Keep out of reach of children

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

  • Directions

    Apply with a cotton ball, sweeping gently over face and neck (Cover the entire affected area with a thin layer) one to two times daily. If dryness or peeling occurs, reduce usage to every other day. It is best for normal, dry, combination and oily skin.

  • Inactive ingredients

    Water(aqua), Propylene glycol, Glycerin, Acetyl glutathione (glutamine), Acrylates/C10-30 alkyl acrylates crosspolymer, Denatured alcohol (40-B), Benzoyl peroxide, Lactic acid, Polysorbate 20, Melaleuca alternifolia (*organic tea tree) leaf oil, Camelia sinesis (*organic green tea)leaf extract, Retinyl Palmitate (vitamin A), Carica (*organic papaya) fruit extract, Sodium ascorbyl phosphate (vitamin C), Bromelain (*organic pineapple steam leaf), Sodium PCA, Allium sativum (*organic garlic) oil, Citrus medica limonium (*organic lemon) fruit extract), Sodium hydroxide, Phenoxyethanol, Glycolic acid, Fragrance parfum

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    SALICYLACNE-1% CLEARING GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    (2S)-3-PHENYLPROPANE-1,2-DIOL (UNII: 6PQ7U3G5W6)  
    ALLIUM SATIVUM WHOLE (UNII: IIF21WT8O3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM PIDOLATE (UNII: 1V74VH163T)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    GLUTAMINE (UNII: 0RH81L854J)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    VITAMIN A (UNII: 81G40H8B0T)  
    CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
    STEM BROMELAIN (UNII: ZLM4P8929R)  
    CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    Product Characteristics
    Color    Score    
    ShapeROUNDSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76523-107-0259.15 mL in 1 JAR; Type 0: Not a Combination Product06/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/17/2021
    Labeler - Valley of the Sun Cosmetics (176470664)
    Registrant - Valley of the Sun Cosmetics (176470664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Valley of the Sun Cosmetics LLC176470664manufacture(76523-107)
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