HYDROGEN PEROXIDE ANTISEPTIC- hydrogen peroxide spray
Acme United Corp

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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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)

HYDROGEN PEROXIDE ANTISEPTIC
hydrogen peroxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-0932
Route of Administration	TOPICAL

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

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

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

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

Labeler - Acme United Corp (001180207)

Registrant - Safetec of America, Inc (874965262)

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