Label: HAND SANITIZER- 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 19, 2020

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

  • Drug Facts

  • Active Ingredient(s)

    Ispropyl alcohol 70% v/v

    Purpose

    Anitmicrobial

  • Use(s)

    Hand sanitizer that can help reduce bacteria that can cause disease. Recommended for repeated use.

  • Warnings

    Flammable. Keep away from heat or flame. For external use only.

    Do not use

    • In children less than two months of age
    • On open skin wounds

    When using this product

    do NOT use near eyes, ears or mouth. In case of contact, rinse 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 the reach of children.

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

  • Direction

    • Place enough product on hands to cover your hands. 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

    glycerin, carbomer, water, fragrance

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69737-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69737-001-003785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - B & J Group (064604222)