HAND SANITIZER- alcohol gel 
Unysource Enterprise

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.

----------

Enviromed 70% Alcohol 4000 mL

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 70% 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, Carbomer, Triethylamine, Fragrance

Package Label - Principal Display Panel

4000ml ET Label

4000 mL NDC: 79505-009-01

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79505-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2800 mL  in 4000 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 20 mL  in 4000 mL
TRIETHYLENE AMINE (UNII: VG267KM5GH) 20 mL  in 4000 mL
GLYCERIN (UNII: PDC6A3C0OX) 80 mL  in 4000 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 20 mL  in 4000 mL
WATER (UNII: 059QF0KO0R) 1060 mL  in 4000 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79505-009-014000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/09/2020
Labeler - Unysource Enterprise (204167139)
Registrant - Unysource Enterprise (204167139)
Establishment
NameAddressID/FEIBusiness Operations
Unysource Enterprise204167139manufacture(79505-009)

Revised: 12/2020
Document Id: b621d9a2-4298-cc55-e053-2a95a90aaa83
Set id: aa947778-f0ee-761f-e053-2995a90a714a
Version: 3
Effective Time: 20201210
 
Unysource Enterprise