Label: ACNE TREATMENT SERUM- salicylic acid lotion

  • NDC Code(s): 72206-003-00
  • Packager: COB Ecommerce Empire LLC
  • 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 August 30, 2018

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active ingredient

    Salicylic acid 0.5%

    Purpose

    Acne treatment

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  • Uses

    • for the treatment of acne
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  • 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.

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  • Directions

    • Clean the skin thoroughly before applying this product
    • 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
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  • Inactive ingredients

    purified water, tea tree oil, glycerin, honeysuckle, chamomile, lecithin, olive oil, coconut oil, lavender oil, chlorophyllin, grape seed extract, hyaluronic acid.

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT SERUM 
    salicylic acid lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72206-003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72206-003-00 1 in 1 CARTON 05/01/2017
    1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 05/01/2017
    Labeler - COB Ecommerce Empire LLC (081031434)
    Establishment
    Name Address ID/FEI Business Operations
    Guangzhou Fu Bao Daily Chemical Co.,Ltd. 544583878 manufacture(72206-003)
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