HYDROGEN PEROXIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amerifoods Trading Co

INN (International Name):

HYDROGEN PEROXIDE

Composition:

HYDROGEN PEROXIDE 30 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First Aid Antiseptic Oral debriding agent - first aid to help prevent the risk of infection in minor cuts, scrapes and burns - aids in the removal of phlgm, mucus, or other secretions assoicated with occasional sore mouth - in the eyes or apply over large areas of the the body - longer than one week 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 SOLUTION
AMERIFOODS TRADING CO
_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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HYDROGEN PEROXIDE TOPICAL SOLUTION USP 3%
871.001/871AA
ACTIVE INGREDIENT
Hydrogen peroxide (stablized) 3%
PURPOSE
First Aid Antiseptic
Oral debriding agent
USE
first aid to help prevent the risk of infection in minor cuts, scrapes
and burns
aids in the removal of phlgm, mucus, or other secretions assoicated
with occasional
sore mouth
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
in the eyes or apply over large areas of the the body
longer than one 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
spray 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
Oral debriding agent (oral rinse): adults and children 2 years of age
and over:
mix with an equal amount of water
swich 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 ago should be supervised in the use
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
sprayer tip away from face when opening.
INACTIVE INGREDIENTS
purified water
ADVERSE REACTIONS
DISTRIBUTED BY: AMERIFOODS TRADING CO.
P.O. BOX 512377, LOS ANGELES, CA 90051-0377
PRINCIPAL DISPLAY PANEL
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