COVISAN- ethyl alcohol liquid 
Flavorcraft Industries, Inc.

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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Hand sanitizer

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. 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. 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

Antiseptic

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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

3.78L NDC: 74593-002-28 - 1 gallon jug 1 gallon front label1 gallon back label

236mL NDC: 74593-002-08 - 8 ounce bottle 8 ounce bottle label

208.19L NDC: 74593-002-55 - 55 gallon drum 55 gallon front label55 gallon back label

59mL NDC: 74593-002-02 - 2 ounce bottle 2 ounce bottle label

473mL NDC: 74593-002-16 - 16 ounce bottle 16 ounce bottle label

18.9L NDC: 74593-002-99 - 5 gallon pail 5 gallon pail front label5 gallon pail back label

COVISAN 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74593-002
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
WATER (UNII: 059QF0KO0R) 18.425 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74593-002-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/13/2020
2NDC:74593-002-55208197 mL in 1 DRUM; Type 0: Not a Combination Product05/05/2020
3NDC:74593-002-9918927 mL in 1 PAIL; Type 0: Not a Combination Product04/20/2020
4NDC:74593-002-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
5NDC:74593-002-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
6NDC:74593-002-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/13/2020
Labeler - Flavorcraft Industries, Inc. (621632921)
Establishment
NameAddressID/FEIBusiness Operations
Flavorcraft Industries, Inc.621632921manufacture(74593-002)

Revised: 5/2020
Document Id: a5747f28-c7aa-05ab-e053-2a95a90af9f6
Set id: a5748136-5dcd-09b9-e053-2a95a90a7aab
Version: 1
Effective Time: 20200512
 
Flavorcraft Industries, Inc.