Label: ACNE DOTS- salicylic acid patch

  • NDC Code(s): 78936-403-01, 78936-403-02
  • Packager: Hangzhou Caring Cleaning Commodity Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 10, 2024

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  • 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 make up.

    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

    Butylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil

  • Package Label - Principal Display Panel

    1234

  • INGREDIENTS AND APPEARANCE
    ACNE DOTS 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78936-403
    Route of AdministrationPERCUTANEOUS
    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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78936-403-0220 in 1 BOX05/10/2024
    1NDC:78936-403-0117 mg in 1 PATCH; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/10/2024
    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(78936-403)
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