HYDROGEN PEROXIDE SPRAY [SAFETEC OF AMERICA, INC.]

HYDROGEN PEROXIDE SPRAY [SAFETEC OF AMERICA, INC.]
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NDC	61010-5400-2, 61010-5400-4
Set ID	a665e2ce-c7e1-4d79-aa58-da7595944e7f
Category	HUMAN OTC DRUG LABEL
Packager	Safetec of America, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333A

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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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/16/2012

Labeler - Safetec of America, Inc. (874965262)

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

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