HAND SANITIZER W/ CARABINER (LEMON SCENTED) 2OZ BONUS PACK (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL INC.]

HAND SANITIZER W/ CARABINER (LEMON SCENTED) 2OZ BONUS PACK (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL INC.]
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NDC 57337-095-01
Set ID 6e6585a3-61e1-30ec-e053-2a91aa0a6039
Category HUMAN OTC DRUG LABEL
Packager Rejoice International Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 70.0% v/v

  • PURPOSE

    Antimicrobial

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children under 6 years in the use of this product
  • INDICATIONS & USAGE

    Use:

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
  • WARNINGS

    Warnings:

    For external use only.

    Flammable. Keep away from heat and flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

  • INACTIVE INGREDIENT

    Inactive Ingredients: water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate (Vitamin E), fd&c blue no. 1, D&C Red no. 33

  • PRINCIPAL DISPLAY PANEL

    image

    image

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER W/ CARABINER (LEMON SCENTED)  2OZ BONUS PACK
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-095-012 in 1 BLISTER PACK06/11/2018
    153 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/11/2018
    Labeler - Rejoice International Inc. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Co., Ltd.529287434manufacture(57337-095)

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