DR.ZIUM ALL CLEAR SPOT (SALICYLIC ACID) CREAM [GM HOLDINGS CO., LTD]

DR.ZIUM ALL CLEAR SPOT (SALICYLIC ACID) CREAM [GM HOLDINGS CO., LTD]
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NDC 69278-001-01
Set ID 63061155-c48e-5bd8-e053-2a91aa0a2e8d
Category HUMAN OTC DRUG LABEL
Packager GM Holdings Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENT

    Salicylic Acid

  • INACTIVE INGREDIENT

    Niacinamide, Terminalia Ferdinandiana Fruit Extract, Aazelaoyl Octapeptide-9, Water, etc

  • PURPOSE

    Acne Treatment

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply an adequate amount to the trouble area and absorb with gentle dabbing

  • WARNINGS

    Warnings

    Do not use if you have very sensitive skin or are sensitive to Salicylic Acid

    Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DR.ZIUM ALL CLEAR SPOT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69278-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.00001 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69278-001-0115 mL in 1 TUBE; Type 0: Not a Combination Product01/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/17/2018
    Labeler - GM Holdings Co., Ltd (688439958)
    Registrant - GM Holdings Co., Ltd (688439958)
    Establishment
    NameAddressID/FEIBusiness Operations
    GM Holdings Co., Ltd688439958label(69278-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(69278-001)

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