Label: INSTANT HAND SANITIZER - COCOA BUTTER- ethyl alcohol gel

  • NDC Code(s): 58503-015-01
  • Packager: China Ningbo Shangge Cosmetic Technology Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 17, 2022

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  • ACTIVE INGREDIENT

    Active IngredientPurpose

    Ethyl Alcohol 62.0%......................Antimicrobial

  • PURPOSE

    Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

    Kills 99.9% of Germs without water or towels!

  • 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.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children in the use of this product
  • INACTIVE INGREDIENT

    Inactive ingredients:

    aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

  • OTHER SAFETY INFORMATION

    Other information:

    • store at 20oC to 25oC (68o to 77oF)
    • may discolor certain fabrics
  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER - COCOA BUTTER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL147 mL  in 237 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-015-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/05/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/05/2013
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-015)
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