HYDROGEN PEROXIDE liquid

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen peroxide 3%

Purpose

first aid antiseptic/oral debriding agent

Uses

Warnings

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)

Do not use

in the eyes or apply over large areas of the body longer than one week
on deep or puncture wounds, animal bites, or on serious burns.

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 this and all drugs out of the reach of children.

If swallowed, seek professional assistance
or contact a Poison Control Center immediately.

Directions

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

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
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 dentist or doctor

Other information

Keep tightly closed and in a dark place at a controlled room temperature.
Do not shake bottle. Hold away from face when opening.

Inactive ingredient

purified water

principal display panel

hydrogen peroxide U.S.P

first aid antiseptic

tamper evident-do not use if

printed safety seal on cap is broken or missing

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0014
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 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: 49580-0014-3	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/04/2013	12/30/2021
2	NDC: 49580-0014-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/04/2013	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	12/04/2013	12/30/2021

Labeler - P & L Development, LLC (101896231)