SANITIZE 75- hand sanitizer gel 
SANITIZE NT-75- hand sanitizer gel 
SANITIZE NT-80- hand sanitizer gel 
SANITIZE 80- hand sanitizer gel 
Manufacturers Chemicals

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.

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Manufacturers Chemicals - Sanitize 80, Sanitize 75, Sanitize NT-80, and Sanitize NT-75

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

  1. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (0.725% v/v).
  3. Copolymer (6 % v/v).
  4. Trolamine (0.3 % v/v).
  5. FD&C Blue No.1 (0.00018 % v/v).
  6. 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# 76747-0275) and Sanitize NT-75 (NDC# 76747-0475)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Sanitize 80 (NDC#76747-0180) and Sanitize NT-80 (76747-0380)

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

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 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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

SANITIZE NT 75 76747-0475-3 SANITIZE 80 - 76747-0180-1 SANITIZE 80 - 76747-0180-2SANITIZE 80 - 76747-0180-3SANITIZE 75 - 76747-0275-1SANITIZE 75 - 76747-0275-2SANITIZE 75 - 76747-0275-3SANITIZE NT-80 76747-0380-1SANITIZE NT-80 76747-0380-2 SANITIZE NT-80 76747-0380-3SANITIZE NT 75 76747-0475-1SANITIZE NT 75 76747-0475-2

SANITIZE 75 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76747-0275
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
TROLAMINE (UNII: 9O3K93S3TK) 1 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:76747-0275-1204412 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:76747-0275-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:76747-0275-318921 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 finalpart333A03/30/2020
SANITIZE NT-75 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76747-0475
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 1.8 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76747-0475-1204412 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:76747-0475-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:76747-0475-318921 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 NT-80 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76747-0380
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 1.8 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76747-0380-1204412 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:76747-0380-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:76747-0380-318921 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:76747-0180
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.8 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) 6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76747-0180-1204412 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:76747-0180-21022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:76747-0180-318921 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
Labeler - Manufacturers Chemicals (968260323)
Establishment
NameAddressID/FEIBusiness Operations
Manufacturers Chemicals968260323manufacture(76747-0275, 76747-0475, 76747-0380, 76747-0180)

Revised: 9/2020
Document Id: ae57122d-12ff-fde1-e053-2a95a90a96b3
Set id: a5f0d027-c23c-0747-e053-2995a90ae6e4
Version: 2
Effective Time: 20200902
 
Manufacturers Chemicals