HYDROGEN PEROXIDE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)

Available from:

P & L Development, LLC

INN (International Name):

HYDROGEN PEROXIDE

Composition:

HYDROGEN PEROXIDE 3 mL in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

first aid antiseptic/oral debriding agent 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. deep or puncture wounds, animal bites or serious burns 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYDROGEN PEROXIDE- HYDROGEN PEROXIDE LIQUID
P & L DEVELOPMENT, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
ACTIVE INGREDIENT
Hydrogen peroxide 3%
PURPOS E
first aid antiseptic/oral debriding agent
US ES
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 ai