Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 47993-299-01, 47993-299-02, 47993-299-03
  • Packager: NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD
  • 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 5, 2020

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  • ACTIVE INGREDIENT

    Active ingredients

    Ethyl Alcohol 62%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses：

    For hand sanitizing to reduce bacteria on the skin.

  • WARNINGS

    Warnings:

    For external use only - hands. 

    Flammable. Keep away from fire and flame.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if skin irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    Squeeze small amount in your palm and briskly rub hands together until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water,Carbomer 940,Triethanolamine,Glycerin,Aloe Barbadensis leaf juice,Vitamin E,Fragrance,Iron Oxide(CI 77499),Iron Oxide(CI 77492),D&C Red No.30

  • PRINCIPAL DISPLAY PANEL

    image of hand sanitizer 30mlimage of hand sanitizer 54mlimage of hand sanitizer 60ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-299
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 112 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-299-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    2NDC:47993-299-0254 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    3NDC:47993-299-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/24/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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