VISCOSE WIPES (ALLIUM CEPA) CLOTH [SIMPLE IDEAS, INC.]

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VISCOSE WIPES (ALLIUM CEPA) CLOTH [SIMPLE IDEAS, INC.]
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NDC 71041-1601-1, 71041-1601-2
Set ID 3ed5f383-e8cd-5a60-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager SIMPLE iDEAS, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Allium Cepa 8x

  • INACTIVE INGREDIENT

    Barley Tea Extract (water, malted barley extract), Potassium Sorbate, Natural Flavor, Ascorbic Acid, Citric Acid, Salt

  • PURPOSE

    To wipe hands thoroughly and reduce itching or skin irritations.

  • WARNINGS

    For external use only.

    Do not swallow wipes. Choking may result.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    To wipe hands thoroughly and reduce itching or skin irritations. Repeat as needed.

    Children: Use only with adult supervision.

  • INDICATIONS & USAGE

    To wipe hands thoroughly and reduce itching or skin irritations. Repeat as needed.

    Children: Use only with adult supervision.

  • PRINCIPAL DISPLAY PANEL

    ProductLabel 2ProductLabel 1CaseLabel 2CaseLabel 1

  • INGREDIENTS AND APPEARANCE
    VISCOSE WIPES 
    allium cepa cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71041-1601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BARLEY (UNII: 5PWM7YLI7R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71041-1601-11000 in 1 PACKAGE; Type 0: Not a Combination Product10/17/2016
    2NDC:71041-1601-21200 in 1 PACKAGE; Type 0: Not a Combination Product10/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/17/2016
    Labeler - SIMPLE iDEAS, Inc. (080034521)
    Registrant - SIMPLE iDEAS, Inc. (080034521)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIMPLE iDEAS, Inc.080034521label(71041-1601)
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