HYDROGEN PEROXIDE solution

Hydrogen peroxide by

Drug Labeling and Warnings

Hydrogen peroxide by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrogen peroxide (stabilized) 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 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
• 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 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

DOSAGE & ADMINISTRATION

Oral debriding agent: adults, children over 2 years of age:

• mix with an equal amount of water
• swish around in the mouth over the affected area for at least 1 minute, then spit out
• use up to 4 times daily after meals and at bedtime
• children under 12 years of age should be supervised in the use
• children under 2 years of age: consult a dentist, doctor

Other information

Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

purified water

SPL UNCLASSIFIED SECTION

www.medline.com

Made in US with US and foreign components for

Medline Industries, Inc., Mundelein, IL 60060 USA.

1-800-MEDLINE

4 oz bottle label

NDC: 53329-080-04

HYDROGEN PEROXIDE 3%

First aid antiseptic

Oral debriding agent

Product sealed for your protection

4 FL OZ

(118 mL)

8 oz bottle label

NDC: 53329-080-08

HYDROGEN PEROXIDE 3%

First aid antiseptic

Oral debriding agent

Product sealed for your protection

8 FL OZ

(236 mL)

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-980
Route of Administration	TOPICAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	3 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: 53329-980-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2015
2	NDC: 53329-980-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/11/2015

Labeler - Medline Industries, Inc. (025460908)