Label: ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE SOLUTION- 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 1, 2020

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  • Drug Facts

  • Active ingredient[s]

    Alcohol 80% 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

    • 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 rash occurs. These may be signs of a serious condition.

    Keep out of reach of chilren.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together continuously 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

    Aloe Vera, Vitamin E, Carbomer, TEA, Deionized Water, Fragrance, fd&c blue no.1

  • Package Labeling:50 ml

    Label

  • Package Labeling:100 ml

    Label2

  • Package Labeling:250 ml

    Label3

  • Package Labeling:500 ml

    Label.4

  • Package Labeling: 1000

    Label5

  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE SOLUTION 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80095-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TEA LEAF (UNII: GH42T47V24)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80095-000-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
    2NDC:80095-000-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
    3NDC:80095-000-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
    4NDC:80095-000-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
    5NDC:80095-000-001000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/12/2020
    Labeler - Pegasus Biotechnology LLC. (121238045)
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