HAND SANITIZER- alcohol gel 
Tri-Chem Industries

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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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:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Aminomethyl propanol (1.5% v/v)
    d. Hydrogen peroxide (0.125% v/v).
  4. 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)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer Gel

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, aminomethyl propanol, purified water USP

Package Label - Principal Display Panel

18.93 L NDC: 74664-002-10

74664-002-10

208.20 L NDC: 74664-002-20

74664-002-20

1041 L NDC: 74664-002-30

74664-002-30

1249.2 L NDC: 74664-002-40

74664-002-40

24605.2 L NDC: 74664-002-50

74664-002-50

118 mL NDC: 74664-002-60

74664-002-60

236 mL NDC: 74664-002-70

74664-002-70


473 mL NDC: 74664-002-80

74664-002-80

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74664-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74664-002-1018927 mL in 1 PAIL; Type 0: Not a Combination Product04/01/2020
2NDC:74664-002-20208198 mL in 1 DRUM; Type 0: Not a Combination Product04/01/2020
3NDC:74664-002-301249000000 mL in 1 TANK; Type 0: Not a Combination Product04/01/2020
4NDC:74664-002-401041000000 mL in 1 TANK; Type 0: Not a Combination Product04/01/2020
5NDC:74664-002-50246050000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Tri-Chem Industries (798244414)
Registrant - Tri-Chem Industries (798244414)
Establishment
NameAddressID/FEIBusiness Operations
Tri-Chem Industries798244414manufacture(74664-002)

Revised: 11/2021
Document Id: cfbcb777-0515-36eb-e053-2a95a90ab0b6
Set id: a51b7267-132c-4559-e053-2a95a90a835c
Version: 2
Effective Time: 20211101
 
Tri-Chem Industries