Label: DOUGLAS - HAND SANITIZER 75 PERCENT- isopropyl 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 June 3, 2020

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  • ACTIVE INGREDIENT

    ISOPROPYL ALCOHOL 75%

  • PURPOSE

    ANTISEPTIC

  • USES

    HEALTH CARE PERSONNEL HAND RUB TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.

    DO NOT USE

    • IN CHILDREN LESS THAN 2 MONTHS OF AGE
    • ON OPEN SKIN WOUNDS

    WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
    • SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.
  • OTHER INFORMATION

    • STORE BETWEEN 15-30°C (58-86°F)
    • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F)
  • INACTIVE INGREDIENTS

    DI WATER, CARBOPOL, PROPYLENE GLYCOL, TEA, FRAGRANCE, POLYSORBATE 20

  • PRINCIPAL DISPLAY PANEL

    01b LBL_2020 Douglas-Hand-Sanitizer-Label-fnl

  • INGREDIENTS AND APPEARANCE
    DOUGLAS - HAND SANITIZER  75 PERCENT
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78510-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78510-101-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - Douglas Pads & Sports, Inc (161798285)
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