Hydrogen Peroxide by JHK Inc / Safetec of America, Inc. HYDROGEN PEROXIDE spray

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by JHK Inc, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrogen Peroxide Topical Solution 3%

Purpose

First aid antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Do not use

• in the eyes or apply over large areas of the body
• longer than one week unless directed by a doctor

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if conditions persist or get worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the affected area
• spray a small amount of this product on the area 1 - 3 times daily
• may be covered with a sterile bandage. If bandaged, let dry first.

Other Information

• store at room temperature

Inactive ingredients

purified water

Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 46561

V1_11-7-19

Principal Display Panel – Bottle Label

0661

NDC: 73598-0661-1

Hydrogen
Peroxide

First Aid Antiseptic

First Aid to Help
Prevent Infection in
Minor Cuts, Scrapes
and Burns.

American Safety
& First Aid

2 fl. oz. (59.1 ml)

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-0661
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V)	Hydrogen Peroxide	30 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73598-0661-1	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/14/2020

Labeler - JHK Inc (867236309)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(73598-0661)