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:

FOODHOLD U.S.A., LLC

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 phlegm, mucus, or other secretions associated with occasional sore mouth - in the eyes or apply over large areas of the body - longer than 1 week deep or pucture 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
FOODHOLD U.S.A., 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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HYDROGEN PEROXIDE
871
ACTIVE INGREDIENT
Hydrogen peroxide (stabilized) 3%
PURPOS E
First Aid Antiseptic
Oral debriding agent
US E
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
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 pucture 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 the product on the affected area 1 to 3 times
a day
may be covered with a sterile bandage
if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age
mix with equal amount of water
swish around in the mouth over the affected area for at least 1
minute, then spit out
use up to 4 times daily after meals and at bedtime
children under 12 years of age 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 away from face
when opening.
INACTIVE INGREDIENT
purified water
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
Quality Guaranteed or your money back
871.001/871AA
PRINCIPAL DISPLAY PANEL
Do not use if printed seal under cap is broken or missing
CAREONE
Hydrogen Peroxide
TOPICAL SOL