HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Henry Schein Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 removal of phlegm, mucous, 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 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 (1-800-222-1222).

Directions

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

  Oral Debriding Agent (oral rinse):

  Adults and children 2 years of age & over:

  • mix with an equal amount of water
  • swish around in the mouth over the affected area for at least 1 minute and then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor

Other Information

• Keep tightly closed in a cool dark place
• Do not shake bottle
• Hold away from face when opening

Inactive Ingredient

Purified Water

Questions or Comments?

1-800-472-4346

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

Item # 112-7070
NDC: 0404-0001-01

HENRY SCHEIN®

3 % Hydrogen
Peroxide Solution

U.S.P. FIRST AID ANTISEPTIC
Tamper evident cap for your protection. If ring-band
is detached from cap or missing do not use.

Distributed by (in US Only):

HENRY SCHEIN INC.
135 Duryea Road
Melville, NY 11747 USA

Rev. Date 2018/06 Made in the USA

128 FL OZ (1 Gal.) 3.79 L

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V)	Hydrogen Peroxide	30 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0001-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2014
2	NDC: 0404-0001-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2014
3	NDC: 0404-0001-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	06/01/2014

Labeler - Henry Schein Inc. (012430880)