Hydrogen Peroxide

Hydrogen Peroxide

Drug Labeling and Warnings

Drug Details

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HYDROGEN PEROXIDE- hydrogen peroxide solution 
Western Family

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
Oral debriding agent

Use

first aid to help prevent the rise of infection in minor cuts, scrapes and burns aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

for external use only

Do not use

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

Ask 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

First aid antiseptic:
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

Western Family Foods, Inc.,
P.O. box 4057
Portland, OR 97208 U.S.A.
www.westernfamily.com

Western Family
First Aid Antiseptic
Hydroge PEROXIDE Topical Solution
FOR TREATMENT of Minor Cuts +Abrasions
DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING
8 FL OZ (237 mL)

871.001/871AA

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-871
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: 55312-871-34	.237 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/1990
2	NDC: 55312-871-43	.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/1990
3	NDC: 55312-871-45	.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/15/1990

Labeler - Western Family (192166072)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(55312-871)

Revised: 12/2018

Document Id: e2068ec2-bbb1-4563-b2bd-a32290e6e5cc

34390-5

Set id: ebd98e52-997d-4cca-a889-c6f6d6b7bd6a

Version: 4

Effective Time: 20181226

 

Western Family