3 PERCENT HYDROGEN PEROXIDE- 3% hydrogen peroxide gel 
Solugen Blending, 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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3% Hydrogen Perxoide, USP

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. Hydrogen peroxide (H2O2) (USP or Food Chemical Codex (FCC) grade) (3%, volume/volume (v/v)) in an aqueous solution .
  2. 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)

Hydrogen Peroxide 3% 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

purified water USP

Package Label - Principal Display Panel

22712 L NDC: 79975-011-01 22712 L NDC:79975-011-01

3 PERCENT HYDROGEN PEROXIDE 
3% hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79975-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 97 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79975-011-0122712000 mL in 1 CONTAINER; Type 0: Not a Combination Product10/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/12/2020
Labeler - Solugen Blending, LLC (117590261)
Establishment
NameAddressID/FEIBusiness Operations
Solugen Blending-Minetta117590261manufacture(79975-011)
Establishment
NameAddressID/FEIBusiness Operations
Solugen Blending-Slaton117605218manufacture(79975-011)

Revised: 10/2020
Document Id: b17abbd0-21d3-0db0-e053-2995a90a2375
Set id: b17aa4bb-895b-0ac5-e053-2a95a90aa857
Version: 1
Effective Time: 20201012
 
Solugen Blending, LLC