Label: VITA SOLUBALL- ascorbic acid, zinc oxide powder

  • NDC Code(s): 84020-0001-1
  • Packager: Silexn Technology Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 23, 2024

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  • ACTIVE INGREDIENT

    Ascorbic acid 200mg, Zinc oxide 40mg per 1000mg

  • INACTIVE INGREDIENT

    silicon dioxide

  • PURPOSE

    Antioxidation, Antiinflammatory on the skin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Sprinkle on the affected area of the skin and rub it.

    Once a day - below 100mg per day

  • WARNINGS

    Stop using it immediately if there are signs of skin rashes or hypersensitivity.

  • DOSAGE & ADMINISTRATION

    for topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    VITA SOLUBALL 
    ascorbic acid, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84020-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 mg  in 1000 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID200 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84020-0001-110000 mg in 1 BOTTLE; Type 0: Not a Combination Product01/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/24/2024
    Labeler - Silexn Technology Co.,Ltd. (987655536)
    Registrant - Silexn Technology Co.,Ltd. (987655536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Silexn Technology Co.,Ltd.987655536manufacture(84020-0001)
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