GEL HAND SANITIZER- alcohol gel 
Willamia Distilling

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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Gel 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

Purpose

Antimicrobial, 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

water, glycerin, thickener, ph balancer, fragrance

Package Label - Principal Display Panel

89ml NDC 74747-004-01 3oz gel

237ml NDC 74747-004-02 8oz gel4473ml NDC 74747-004-03 16oz gel

946ml NDC 74747-004-04 32oz gel33667ml NDC 74747-004-05 gallon gel

1041l NDC 74747-004-06 275 gallon tote gel

GEL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74747-004
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
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74747-004-0189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/2020
2NDC:74747-004-02237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/2020
3NDC:74747-004-03473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/2020
4NDC:74747-004-04946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/2020
5NDC:74747-004-053667 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/2020
6NDC:74747-004-061041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/09/2020
Labeler - Willamia Distilling (117476529)
Establishment
NameAddressID/FEIBusiness Operations
Willamia Distilling117476529manufacture(74747-004)

Revised: 9/2020
Document Id: ae6dfa4c-495a-2513-e053-2995a90a4843
Set id: a22f6fe5-256a-7918-e053-2a95a90afc44
Version: 5
Effective Time: 20200903
 
Willamia Distilling