Label: HAND SANITIZER LIME- alcohol gel

  • 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 January 1, 2018

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  • Active ingredient

    Alcohol 62%

    Purpose

    Antiseptic Hand Sanitizer

  • Use

    Decrease bacteria on hands

  • Warnings

    External Use Only. DONO EAT.

    Keep out of reach of children

    if swallowed

    get medical help or contact a Poison Control Center right away.

  • Directions

    Rub hands thoroughly with product and allow to dry.

  • Inactive Ingredient

    Carbomer, Glycerin, Jojoba Particles, Lime Extract, Pigment Red GB106-3040, Pigment Yellow 109C, Propylene Glycol, Triethanolamine, Water.

  • Stop and Ask a doctor if

    Irritation or redness develop.

  • HAND SANITIZER (ALCOHOL) GEL

    Label Image
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER LIME 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71246-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)  
    PIGMENT RED 1 (UNII: D54Q24K2EI)  
    PIGMENT YELLOW 109 (UNII: AFB0QQM2VZ)  
    JOJOBA ACID (UNII: MO7HV04S9Y)  
    LIME OIL (UNII: UZH29XGA8G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71246-4001-140 mL in 1 POUCH; Type 0: Not a Combination Product02/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A02/01/2017
    Labeler - JFL ENTERPRISES, INC (010967011)
    Establishment
    NameAddressID/FEIBusiness Operations
    NingBo Huize Commodity Co.,Ltd.544434795manufacture(71246-4001)
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