Label: BERKLEY JENSEN INSTANT SANITIZER- ethyl 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 January 14, 2015

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 65%

    PURPOSE

    ANTISEPTIC

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN

  • WARNINGS

    • FOR EXTERNAL USE ONLY
    • FLAMMABLE
    • KEEP AWAY FROM SOURCE OF HEAT OR FIRE

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

  • DIRECTIONS

    WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

  • OTHER INFORMATION

    STORE AT A TEMPERATURE BELOW 110°F (43°C)

  • INACTIVE INGREDIENTS

    WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE

  • QUESTIONS OR COMMENTS?

    1-800-934-1204

  • LABEL COPY

    IMAGE OF THE LABEL

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    BERKLEY JENSEN  INSTANT SANITIZER
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-167
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-167-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:68391-167-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/13/2015
    Labeler - BJWC (159082692)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(68391-167)
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