Hydrogen Peroxide

Hydrogen Peroxide

Drug Labeling and Warnings

Drug Details

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HYDROGEN PEROXIDE- hydrogen peroxide solution 
DZA Brands,

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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Hydrogen Peroxide

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic

Use

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use

in the eyes or apply over large areas of the body longer than 1 week

As a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

the condition persists or gets worse 

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the affected area
apply a small amount of product on the affected area 1 to 3 times a day
may be covered with a sterile bandage
if bandaged, let dry first

Other information

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredient

purified water

Distributed by: DZB Brands, LLC
2110 Executive Drive
Salisbury, NC 28147

For product questions or concerns contact us at 1-866-322-2439. Please include UPC number and code from package.

Hydrogen Peroxide Topical Solution USP
First aid antiseptic
oral debriding agent
Sealed with printed neckband for your protection
16 FL OZ (1 PT) 473 mL

871.00/871AA

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-871
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	.3 kg  in 100 L

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-871-43	.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/2009
2	NDC: 55316-871-45	.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/22/2009

Labeler - DZA Brands, (090322194)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(55316-871)

Revised: 12/2018

Document Id: fa4b283c-0255-4bba-aa96-48476c19a4d6

34390-5

Set id: 9af1a6a8-d379-4100-8301-f7f0a3c41e9b

Version: 5

Effective Time: 20181226

 

DZA Brands,