Label: SALICYLACNE-2% CLEARING SERUM- salicylic acid liquid

  • 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 16, 2021

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  • Active Ingredients

    Salicylic Acid 2%

  • 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.

  • Stop use and ask doctor

    If irritation or sensitivity occurs, stop use of product and consult doctor.

  • Keep out of reach of children

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

  • Directions

    Clean the skin thoroughly before applying this product. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by a doctor.

  • Inactive ingredients

    Water (aqua), vegetable (kosher) glycerin, propylene glycol (kosher), alcohol, retinol (vitamin A), tocopheryl acetate (vitamin E), azelaic acid, gluthathione, lactic acid, sodium ascorbyl phosphate (Vitamin C), carica papaya (papaya) fruit extract, citrus paradise (*organic grapefruit) fruit extract, citrus medica limonum (*organic lemon) extract, bromelain (*pineapple stem leaf), sulfur, sodium PCA, PPG-5-Ceteth-20, PEG-40 hydrogenated (castor oil), potassium sorbate, phenoxyethanol, hydroxyethylcellulose, carbomer, citric acid, sodium hydroxide

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    SALICYLACNE-2% CLEARING SERUM 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    VITAMIN A (UNII: 81G40H8B0T)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
    CITRUS PARADISI WHOLE (UNII: 3FNT9K2294)  
    STEM BROMELAIN (UNII: ZLM4P8929R)  
    TECHNETIUM TC-99M SULFUR COLLOID (UNII: 556Q0P6PB1)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)), SODIUM SALT (UNII: T52TI8BMQ6)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    3-HEXYLOXYPROPYLENE GLYCOL (UNII: 3485P35DA4)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    Product Characteristics
    ColorgrayScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76523-020-3030 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2021
    Labeler - Valley of the Sun Cosmetics LLC (176470664)
    Registrant - Valley of the Sun Cosmetics LLC (176470664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Valley of the Sun Cosmetics LLC176470664manufacture(76523-020)
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