Label: HAND SANITIZER - ASTI- 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 May 18, 2020

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

  • Active Ingredient(s)

    Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    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

  • WHEN USING

    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.

  • STOP USE

    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

    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

    purified water USP, Propanediol, Aloe Barbadensis Leaf Juice, Ammonium Mcryloyl Dimethyltaurate/Carboxyethyl Acrylate Crosspolymer, Tocopheryl Acetate

  • Package Label - Principal Display Panel

    177 ml NDC: 74624-001-01 Hand Sanitizer 177 ml

    473 ml NDC: 74624-001-02

    Hand Sanitizer 473 ml

    946 ml NDC: 74624-001-03 Hand Sanitizer 946 ml

    3785 ml NDC: 74624-001-04 Hand Sanitizer 3785 ml

    18927 ml NDC: 74624-001-05 - Hand Sanitizer 18927 ml

    113562 ml NDC: 74624-001-06 Hand Sanitizer 113562 ml

    208198 ml NDC: 74624-001-07 Hand Sanitizer 208198 ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER - ASTI 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74624-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.04 mL  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 2 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 21.36 mL  in 100 mL
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI) 1.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74624-001-01177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    2NDC:74624-001-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    3NDC:74624-001-03946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    4NDC:74624-001-043785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    5NDC:74624-001-0518927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    6NDC:74624-001-06113562 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    7NDC:74624-001-07208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/18/2020
    Labeler - Total Import Solutions, Inc. (848620733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Total Import Solutions, Inc.848620733manufacture(74624-001)