Label: HAND SANITIZER- 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 22, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ALCOHOL 80% v/v

  • PURPOSE

    ANTISEPTIC

  • USES

    HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

    DO NOT USE

    • ON 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, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND 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 (59-86°F)
    • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F)
  • INACTIVE INGREDIENTS

    PURIFIED WATER USP, CARBOMER, AMINOMETHYL PROPANOL, DENATONIUM BENZOATE

  • PRINCIPAL DISPLAY PANEL

    LB_HandSanitizer_Sinno_Label_50ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50069-102(NDC:75497-102)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50069-102-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    2NDC:50069-102-1250 mL in 1 TUBE; Type 0: Not a Combination Product04/23/2020
    3NDC:50069-102-1350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2020
    Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)