HAND SANITIZER GEL WITH FRAGRANCE- isopropyl 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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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:

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Triethanolamine.
  5. Propylene glycol.
  6. Acrylic copolymer or carbomer.
  7. Fragrance.
  8. Sterile distilled water or boiled cold water.

The formulation meets the required efficacy for the protection of human health from germs and viruses when used in the absence of water and soap.

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

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, triethanolamine, propylene glycol, acrylic copolymer and/or carbomer, fragrance, purified water USP

Package Label - Principal Display Panel

118 mL NDC:74664-007-01 74664-007-01236 mL NDC: 74664-007-02 74664-007-02473 mL NDC: 74664-007-03 74664-007-0318900 mL NDC: 74664-007-04 74664-007-0420800 mL NDC: 74664-007-05 74664-007-051041000 mL NDC: 74664-007-06 74664-007-0612491000 mL NDC: 74664-007-07 74664-007-0724605000 mL NDC: 74664-007-08 74664-007-08

HAND SANITIZER GEL WITH FRAGRANCE 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74664-007
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
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.367 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74664-007-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
2NDC:74664-007-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
3NDC:74664-007-0318900 mL in 1 PAIL; Type 0: Not a Combination Product09/18/2020
4NDC:74664-007-051041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/18/2020
5NDC:74664-007-061249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/18/2020
6NDC:74664-007-0724605000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/18/2020
7NDC:74664-007-0420800 mL in 1 DRUM; Type 0: Not a Combination Product09/18/2020
8NDC:74664-007-08473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/18/2020
Labeler - Tri-Chem Industries (798244414)
Registrant - Tri-Chem Industries (798244414)
Establishment
NameAddressID/FEIBusiness Operations
Tri-Chem Industries798244414manufacture(74664-007) , label(74664-007) , pack(74664-007) , repack(74664-007) , relabel(74664-007)

Revised: 9/2020
Document Id: affbbd57-673d-1ef3-e053-2995a90aa99e
Set id: affbbd57-674b-1ef3-e053-2995a90aa99e
Version: 1
Effective Time: 20200923
 
Tri-Chem Industries