Label: PROPOLIS HAND SANITIZER- ethyl 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 April 25, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL 70% 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

    • 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 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 15-30C (59-86F)
    • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)
  • INACTIVE INGREDIENTS

    WATER (AQUA), METHYL GLUCETH-20, CARBOMER, AMINOMETHYL PROPANOL, PROPOLIS EXTRACT, ALOE BARBADENSIS LEAF JUICE, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, TOCOPHERYL ACETATE

  • QUESTIONS?

    1-800-935-IDEN  *  1-800-935-4336

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Hand Sanitizer_4oz

  • INGREDIENTS AND APPEARANCE
    PROPOLIS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74048-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74048-101-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:74048-101-11300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2020
    3NDC:74048-101-121000 mL in 1 PACKAGE; Type 0: Not a Combination Product04/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - Iden Cosmetics, Inc. (067502042)
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