Label: SPOT ON ACNE PATCH- salicylic acid patch

  • 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 10, 2023

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  • ACTIVE INGREDIENT

  • USE

    for treatment of acne

  • WARNINGS

    For external use only

    Do not use

    Do not use if you are allergic to the patch or any of its components

    Keep out of reach of children.

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

    Stop use

    Stop use and ask a doctor if skin irritation occurs.

  • Directions

    Cleanse and thoroughly dry your face. Remove patch adn apply directly onto the blemish. Leave patch on for at least 6 hours. Best used within 10 days after opening.

  • Inactive Ingredients

    Acrylates Copolymer, Water, Denatured Alcohol , Vinyl Caprolactam/ VP/Dimethylaminoethyl Methacrylate Copolymer, Butylene Glycol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Vitis Vinifera (Grape) Seed Extract, Volcanic Ash, Kaolin, PVP, Phenoxyethanol, Polysorbate 80, Sodium Hyaluronate, Sodium Metabisulfite, Phytosphingosine.

  • Purpose

    Spot on Acne Patch label

  • Package label

    Spot On Acne Patch label

  • INGREDIENTS AND APPEARANCE
    SPOT ON ACNE PATCH 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.24 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Product Characteristics
    Color    Score    
    ShapeSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80861-111-0136 in 1 CARTON; Type 0: Not a Combination Product04/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00604/24/2023
    Labeler - ACNEFREE, LLC (122237140)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kovas Co., Ltd688783559manufacture(80861-111)
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