Label: INSTANT HAND SANITIZER FRESH LEMON SCENTED- alcohol liquid

  • 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 August 3, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose:

    Antiseptic


  • INDICATIONS & USAGE


    Uses:

        * Hand Sanitizer to help decrease bacteria on the skin.
      
        * Recommended for repeated use.
  • WARNINGS


    Warnings:

    For external use only

    Flammable

    Keep away from fire or flame

    Keep out of eyes
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of Reach of Children
    Children must be supervised in use of this product


  • ASK DOCTOR


    Stop use and seek a doctor if redness or irritation develop and persist for more than 72 hours.
  • DOSAGE & ADMINISTRATION


    Directions:

    Apply to hands freely without water. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.
  • STORAGE AND HANDLING


    Other Information

    Store at 20C (68-77F)

    Do not store above 40C (105F)

    May discolor fabrics
  • INACTIVE INGREDIENT


    Inactive Ingredients:

    Water, Triethanolamine, Carbomer, Aloe Barbadensis Gel, Glycerin, Propylene Glycol, Tocopherol, FD and C Blue No. 1, FD and C Yellow No. 5
  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER FRESH LEMON SCENTED 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51335-005
    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
    WATER (UNII: 059QF0KO0R) 34.289 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51335-005-0160 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2012
    Labeler - Ningbo Heyi Daily Chemical Products Co., Ltd. (421258415)
    Registrant - Ningbo Heyi Daily Chemical Products Co., Ltd. (421258415)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Heyi Daily Chemical Products Co., Ltd.421258415manufacture(51335-005)
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