Label: ANTIMICROBIAL HAND- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 14, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% w/w

    Purpose

    Antimicrobial

  • Use

    hand sanitizer to help reduce microbes on the skin

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

    When using this product,

    do not use in or near the eyes. If contact occurs, rinse thoroughly with water

    Stop use and ask a doctor

    if irritation and redness develops and persists for more than 72 hours and continues

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • put enough gel in your palm to cover hands and rub hands together rapidly until dry
    • children under 6 years of age should be supervised when using this product
  • Other information

    • store below 110 oF (43 oC)
    • may discolor certain fabrics or surfaces
  • Inactive ingredients

    carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

  • Package Labeling:

    Bottle60ml

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72487-008
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72487-008-0260 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 finalpart333E05/01/2020
    Labeler - Calego International Inc. (081320445)
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