Label: ACNE BUSTER- salicylic acid patch

  • NDC Code(s): 78936-411-01, 78936-411-10
  • Packager: Hangzhou Caring Cleaning Commodity Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 21, 2024

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

  • Active ingredient

    Salicylic Acid, 0.5%. Purpose: Acne treatment

  • Purpose

    Acne treatment

  • Uses

    Soothe and help diminish the redness and irritation of blemished skin & absorbs excess oil for faster healing.

  • 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

    Keep out of reach of children.

  • Directions

    Cleanse and dry face, removing any makeup. Apply one healing dot, sticky side down, over your blemish. Leave the healing dot over blemish for at least 6 hours or overnight. Repeat as necessary with a new healing dot.

  • Inactive ingredients

    Acrylates/Ethylhexyl Acrylate Copolymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Hyaluronate.

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    ACNE BUSTER 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78936-411
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLATE/BUTYL ACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (4:3:3) (UNII: QGG6J9Q3S5)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78936-411-1040 in 1 BOX06/21/2024
    1NDC:78936-411-0117 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/21/2024
    Labeler - Hangzhou Caring Cleaning Commodity Co., Ltd (413905445)
    Registrant - Hangzhou Caring Cleaning Commodity Co., Ltd (413905445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Caring Cleaning Commodity Co., Ltd413905445manufacture(78936-411)