Label: RUE21 DOUGHNUT SPRINKLES ANTIBACTERIAL HAND SANITIZER - alcohol liquid

  • NDC Code(s): 50563-132-01
  • Packager: ENCHANTE ACCESSORIES INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 63%

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  • PURPOSE

    Purpose

    Antiseptic

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  • INDICATIONS & USAGE

    Uses

    To decrease bacteria on the skin

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  • WARNINGS

    For external use only

    When using this product: Keep out of eyes. Do not inhale or ingest.

     


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  • ASK DOCTOR

    Stop use and ask a doctor if skin irritation develops

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical assistance.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime size drop into hands
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  • STORAGE AND HANDLING

    Other Information:

    • Do not store above 105F
    • May discolor some fabrics
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  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

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  • PRINCIPAL DISPLAY PANEL

    lablabel

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  • INGREDIENTS AND APPEARANCE
    RUE21 DOUGHNUT SPRINKLES ANTIBACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50563-132
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 63 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER 33.79985 mL  in 100 mL
    CARBOMER COPOLYMER TYPE A  
    TROLAMINE  
    EDETATE DISODIUM  
    D&C RED NO. 33  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    FD&C YELLOW NO. 6  
    FD&C RED NO. 40  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50563-132-01 29 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 07/09/2013
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
    Establishment
    Name Address ID/FEI Business Operations
    Zhejiang Aidi Cosmetics Co., Ltd. 530876820 manufacture(50563-132)
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