HYDROGEN PEROXIDE ANTISEPTIC- hydrogen peroxide spray

Hydrogen Peroxide Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrogen Peroxide 3.0%

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
• over larger areas of the body
• longer than 1 week unless directed by a doctor

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

Stop use and ask a doctor

• in case of deep puncture wounds, animal bites, or serious bums
• if condition persists or gets worse

Directions

• spray a small amount over cleaned affected area 1 to 3 times daily
• if bandaged, let dry first

Inactive ingredient

purified water

Principal Display Panel - Bottle Label

13-090

ANTISEPTICS

FIRST AID ONLY®

Hydrogen Peroxide
Antiseptic Spray

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

4 fl oz (118.3 ml)

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE ANTISEPTIC 
hydrogen peroxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0932
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 mL  in 1 L

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0932-01	0.1183 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/06/2014

Labeler - Acme United Corp (001180207)

Registrant - Safetec of America, Inc (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc		874965262	MANUFACTURE(0924-0932)