HYDROGEN PEROXIDE liquid

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

 Hydrogen peroxide 3%

Purpose

First aid antiseptic/oral debriding agent 

Uses

• first aid to help prevent the risk 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 than one week

Ask a doctor before use if you have

• deep puncture wounds, animal bites or serious burns

Stop use and ask a docotr if

• the condition persists or gets worse
• sore mouth symptoms do not improve in 7 days
• irritation, pain or redness persists or worsens
• swelling, rash, or fever develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions

For use as a first aid antiseptic:

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

For use as an oral debriding agent (oral rinse):

• adults and children 2 years of age and over:
  • mix with an equal amount of water
  • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
• children under 12 years should be supervised in the use of this product
• children under 2 years of age: consult a doctor or dentist 

Other information

• keep tightly closed and in a dark place at room temperature
• do not shake bottle. Hold away from face when opening.

Inactive ingredient

purified water 

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

3% USP Hydrogen Peroxide

FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

• For treatment of minor cuts, scrapes and burns
• For use as an antiseptic gargle or rinse

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Package Label

TOPCARE HEALTH 3% USP Hydrogen Peroxide

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.65 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-214-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2009
2	NDC: 36800-214-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	05/15/2009

Labeler - TOP CARE (Topco Associates LLC) (006935977)