HYDROGEN PEROXIDE 3%- hydrogen peroxide liquid
Ashahi Chemicals USA 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.

----------

Hydrogen Peroxide 3%

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

in children less than 2 months of age
on open skin wounds

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

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP

Package Label - Principal Display Panel

946 mL NDC: 80866-002-01

32oz

3785 mL NDC: 80866-002-02

1gal

HYDROGEN PEROXIDE 3%
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80866-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	3 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80866-002-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2020
2	NDC:80866-002-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020	03/30/2020

Labeler - Ashahi Chemicals USA LLC (111671300)

Name	Address	ID/FEI	Business Operations
Establishment
Ashahi Chemicals USA LLC		111671300	manufacture(80866-002) , label(80866-002) , pack(80866-002)

Revised: 9/2021

Document Id: cbce3eab-121c-398f-e053-2995a90aadc9

Set id: b1a38760-c7e1-0d2a-e053-2995a90a6325

Version: 2

Effective Time: 20210912

Ashahi Chemicals USA LLC