Label: SANITIZE NT-75- hand sanitizer gel
SANITIZE 80- hand sanitizer gel
SANITIZE NT-80- hand sanitizer gel
SANITIZE 75- hand sanitizer 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 2, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    Sanitize 80

    a. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    b. Glycerol (0.725% v/v).
    c. Copolymer (6 % v/v).
    d. Trolamine (0.3 % v/v).
    e. FD&C Blue No.1 (0.00018 % v/v).
    f. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

    Sanitize NT-80

    a. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    b. Glycerol (0.725% v/v).
    c. Hydroxyethyl Cellulose (1.8 % v/v).

    d. Trolamine (0.3 v/v).

    e. FD&C Blue No.1 (0.00018 % v/v).
    e. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

    Sanitize 75

    a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

    b. Glycerol (0.725 % v/v).
    c. Copolymer (8.2 % v/v).
    d. Trolamine (1 % v/v)
    e. FD&C Blue No.1 (0.00018 % v/v).
    f. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

    Sanitize NT-75

    a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    b. Glycerol (0.725% v/v).
    c. Hydroxyethyl Cellulose (1.8 % v/v).

    d. Trolamine (0.3 v/v).

    e. FD&C Blue No.1 (0.00018 % v/v).
    e. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Sanitize 75 (NDC# 76748-0275 and Sanitize NT-75 (NDC# 76748-0475)

    Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

    Sanitize 80 (NDS# 76748-0180) and Sanitize NT-80 (NDC# 76748-0380)

    Ethanol 80% 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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    SANITIZE 80 76748-0180-1SANITIZE 80 76748-0180-2SANITIZE 80 76748-0180-3SANITIZE NT-80 76748-0380-1SANITIZE NT-80 76748-0380-2 SANITIZE NT-80 76748-0380-3SANITIZE 75 76748-0275-1 SANITIZE 75 76748-0275-2SANITIZE 75 76748-0275-3SANITIZE NT 75 76748-0475-1SANITIZE NT 75 76748-0475-2 SANITIZE NT 75 76748-0475-3

  • INGREDIENTS AND APPEARANCE
    SANITIZE NT-75 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76748-0475
    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
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 1.8 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL  in 100 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76748-0475-1204412 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    2NDC:76748-0475-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
    3NDC:76748-0475-318921 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    SANITIZE 80 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76748-0180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL  in 100 mL
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) 6 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.8 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76748-0180-1204412 mL in 1 DRUM; Type 0: Not a Combination Product05/15/2020
    2NDC:76748-0180-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product05/15/2020
    3NDC:76748-0180-318921 mL in 1 PAIL; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/08/2020
    SANITIZE NT-80 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76748-0380
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 1.8 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76748-0380-1204412 mL in 1 DRUM; Type 0: Not a Combination Product05/15/2020
    2NDC:76748-0380-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product05/15/2020
    3NDC:76748-0380-318921 mL in 1 PAIL; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2020
    SANITIZE 75 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76748-0275
    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
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) 8.2 mL  in 100 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76748-0275-1204412 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    2NDC:76748-0275-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
    3NDC:76748-0275-318921 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/27/2020
    Labeler - CRI Tolling (050981474)
    Establishment
    NameAddressID/FEIBusiness Operations
    CRI Tolling050981474manufacture(76748-0475, 76748-0180, 76748-0380, 76748-0275)
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