Label: ACNE FIGHTING SPOT GEL- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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  • Drug Facts

  • Active ingredients

    Salicylic Acid 1%

    Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Helps prevent new acne blemishes
  • 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

    Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer 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 eleswhere on this label.

  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Water (Aqua), Alcohol Denat., Butylene Glycol, Polyacrylate Crosspolymer-6, Camphor, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, T-Butyl Alcohol, Sodium Benzoate, Phenoxyethanol, Denatonium Benzoate

  • Questions or comments

    1-888-315-9814

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ACNE FIGHTING SPOT GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-414-011 in 1 CARTON02/25/2022
    17.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/25/2022
    Labeler - e.l.f. Cosmetics, Inc (093902816)
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