HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical 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 the 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 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 area 1 to 3 times daily May be covered with a sterile bandage If bandaged, let dry first	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 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 and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

purified water

SPL UNCLASSIFIED SECTION

Distributed By McKesson Medical-Surgical Inc.
Richmond, VA 23228

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 68599-2301-6

McKESSON

Hydrogen

Peroxide 3%

TOPICAL SOLUTION USP
FIRST AID ANTISEPTIC
ORAL DEBRIDING AGENT

For treatment of minor cuts and abrasions.
For use as a gargle or rinse. Tamper evident cap
for your protection. If ring-band is detached from
cap or missing, do not use.

16 FL OZ (1 pt)
(473 mL)

MFR # 23-D0012

Distributed By McKesson Medical-Surgical Inc.

Richmond, VA 23233

LU-5750-1112 1-07-D0012R10

Made in USA

PRINCIPAL DISPLAY PANEL - 473 mL Drug facts panel

Drug Facts

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-2301
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: 68599-2301-2	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2013
2	NDC: 68599-2301-6	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2013
3	NDC: 68599-2301-9	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/09/2013

Labeler - McKesson Medical-Surgical Inc. (023904428)