HYDROGEN PEROXIDE- hydrogen peroxide liquid
Afassco Inc.

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 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

Hydrogen
Peroxide
Spray

First Aid Antiseptic Spray

Cleans and Irrigates Wounds
Fights Infection

#625 2 Fl. Oz. (59 mL)

Mfd. For
Afassco
MINDEN, NV 89423

afa03-0001-01

res

HYDROGEN PEROXIDE
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51532-5400
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 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:51532-5400-1	0.059 L 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	12/31/2023

Labeler - Afassco Inc. (609982723)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(51532-5400)

Revised: 1/2023

Document Id: 244c436f-016b-40e2-9c02-0f2514be5c8c

Set id: d8979711-4d8f-4363-99c3-865f9c2c7e48

Version: 4

Effective Time: 20230112

Afassco Inc.