Hydrogen Peroxide by 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 Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

• near eyes or mucous membranes
• on deep or puncture wounds, animal bites, or serious burns

Keep out of reach of children.

Caution

• not for use on large areas of the body
• if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician

Directions

• spray over affected area
• if bandaged, let dry first

Inactive ingredients

purified water

PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

NDC: 61010-5400-2

Safetec

Hydrogen
Peroxide Spray

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

2 fl. oz. (59.1ml)
Reorder no. 53001

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5400
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: 61010-5400-2	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/16/2012
2	NDC: 61010-5400-4	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/16/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/16/2012

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5400)