Label: HAND SANITIZER ALCOHOL ANTISEPTIC 73- 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 September 8, 2020

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  • Drug Facts

  • Active ingredient[s]

    Alcohol 73% v/v

    Purpose

    Antiseptic

  • Use[s]

    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 with eyes, rinse eyes 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 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, carbomer 940, 2 – amino – 2 – methyl – 1 – propanol, glycerol

  • Package Labeling:59ml

    Label

  • Package Labeling:118ml

    Label2

  • Package Labeling:237ml

    Label3

  • Package Labeling:355ml

    Label4

  • Package Labeling:1L

    Label5

  • Package Labeling:3.785L

    Label6

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER ALCOHOL ANTISEPTIC 73 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90005-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.73 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90005-000-02200 in 1 BOX09/01/2020
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:90005-000-0435 in 1 BOX09/01/2020
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:90005-000-0824 in 1 BOX09/01/2020
    3237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:90005-000-1224 in 1 BOX09/01/2020
    4355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:90005-000-3312 in 1 BOX09/01/2020
    51000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:90005-000-004 in 1 BOX09/01/2020
    63785 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - Precision Chemical Technologies Inc (246543409)
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