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 July 13, 2020

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  • DIRECTIONS

    PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, CARBOMER, TRIETHANOLAMINE

  • DIRECTIONS

    PUT ENOUGH PRODUCT IN YOU PALM TO COVER HANDS AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.

  • KEEP OUT OF REACH OF CHILDREN

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

  • PURPOSE

    ANTIMICROBIAL

  • WARNINGS

    FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE EYES.

    IN CASE OF CONTACT, FLUSH THORUOUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEARS OR LASTS.

  • ACTIVE INGREDIENT

    ETHYL ALCOHOL

  • WARNINGS

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

    FOR EXTERNAL USE ONLY

  • HAND SANITIZER GEL

    LABEL 250 mL BYE VIRUSLABEL 500 mL BYE VIRUSLABEL 1000 mL BYE VIRUSLABEL 19000 mL BYE VIRUSLABEL 500 mL AMDAYLABEL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76560-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL  in 1 mL
    CARBOMER 980 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
    TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL  in 1 mL
    Product Characteristics
    Color    Scorescore with uneven pieces
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76560-0001-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    2NDC:76560-0001-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    3NDC:76560-0001-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    4NDC:76560-0001-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    5NDC:76560-0001-61000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    6NDC:76560-0001-819000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/2020
    Labeler - Plásticos las Palmas, S.A. de C.V. (589192967)
    Registrant - Plásticos las Palmas, S.A. de C.V. (589192967)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plásticos las Palmas, S.A. de C.V.589192967manufacture(76560-0001)
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