HAND SANITIZER- alcohol gel 
Premier Essential Solutions, LLC

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 April, 12, 2019 FDA Final Monograph 84FR14847.

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):

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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. Sterile distilled water or boiled cold water.
  3. Carbomer.
  4. fragrance.
  5. glycerin.
  6. hydrogen peroxide.
  7. sodium hydroxide.

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

carbomer, fragrance, glycerin, hydrogen peroxide, sodium hydroxide, purified water USP

Package Label - Principal Display Panel

473 ml label473mL NDC: 80699-001-01

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80699-001
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
CARBOMER 1342 (UNII: 809Y72KV36)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R) 25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80699-001-011 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - Premier Essential Solutions, LLC (117635716)
Establishment
NameAddressID/FEIBusiness Operations
Premier Essential Solutions, LLC117635716repack(80699-001) , manufacture(80699-001)

Revised: 10/2020
Document Id: b0c6af0a-2baa-9a34-e053-2995a90a9057
Set id: b0c6bfd0-1e95-927e-e053-2995a90aa7b0
Version: 1
Effective Time: 20201015
 
Premier Essential Solutions, LLC