Label: MY BEAUTY SPOT ACNE BUSTER- salicylic acid 0.5% patch

  • NDC Code(s): 56136-182-01, 56136-182-02, 56136-182-03
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 20, 2024

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  • Drug Facts

  • Active Ingredients

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Uses

    soothe and helps diminish the redness and irritation of blemished skin and absorbs excess oil for faster healing.

  • Directions

    • Cleanse and dry facem, removing and 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

    Calcium Carboxymethyl Cellulose, polysilicone-2, Butylene Glycol. Polyurethan polymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, May contain: FD&C Red No. 40 (CI 16035) FD&C RED NO. 4 (CI14700), FD&C YELLOW NO. 5 (CI19140),FD&C BLUE NO.1 (CI42090)

  • 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.
    • The ingredients used in this product meet the highest standards of quality and are infrequent instances of sensitivity, sould this occur, discontinue use immediately.
  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away

  • Product Packaging

    Carton

  • INGREDIENTS AND APPEARANCE
    MY BEAUTY SPOT ACNE BUSTER 
    salicylic acid 0.5% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-182-0120 in 1 PACKAGE03/20/2024
    10.036 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:56136-182-0220 in 1 PACKAGE03/20/2024
    20.0216 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:56136-182-0320 in 1 PACKAGE03/20/2024
    30.0165 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/20/2024
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-182)
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