Label: HAND SANITIZER gel

  • NDC Code(s): 47993-246-01, 47993-246-02
  • 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 4, 2020

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  • ACTIVE INGREDIENT

    Active ingredients

    Ethyl Alcohol 70%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses：

    For hand sanitizing to readuce bacteria on the skin.

  • WARNINGS

    Warnings:

    Flammable. Keep away from fire or flame. For external use only. Keep out of reach of children. Keep out of reach of eyes.

  • 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

  • PRINCIPAL DISPLAY PANEL

    60ml

    237ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 112 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E) 12 g  in 112 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 112 mL
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-246-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    2NDC:47993-246-02237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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