Label: INSTANT HAND SANITIZER WITH MOISTURIZERS OCEAN 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 9, 2010

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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.
        * When water, soap and towel are not available
        * Recommended for repeated use.
  • WARNINGS


    Warnings:

    For external use only

    Flammable

    Keep away from fire or flame

    Do not store above 40 C (105F)

    Do not use in mouth, ears, and eyes

    When using this product, avoid contact with eyes

    In case of contact, flush eyes with water

    Stop use and seek a doctor if redness or irritation develop and persist for more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN


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


  • DOSAGE & ADMINISTRATION


    Directions:

    Place enough product in your palm to thoroughly cover your hands

    Rub into skin until dry
  • STORAGE AND HANDLING


    Other Information

    Store at 20C (68-77F)

    May discolor fabrics
  • INACTIVE INGREDIENT


    Inactive Ingredients:

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


    label
    label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER WITH MOISTURIZERS OCEAN SCENTED 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51335-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 34.29 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2.257 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.375 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.3 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.007 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.315 g  in 100 g
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.006 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.05 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51335-003-01237 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/09/2010
    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
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