DEBROX- carbamide peroxide liquid

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)

थमां उपलब्ध:

Denison Pharmaceuticals, LLC.

प्रशासन का मार्ग:

AURICULAR (OTIC)

प्रिस्क्रिप्शन प्रकार:

OTC DRUG

चिकित्सीय संकेत:

Earwax removal aid for occasional use as an aid to soften, loosen, and remove excessive earwax - ear drainage or discharge - ear pain - irritation or rash in the ear - dizziness - an injury or perforation (hole) of the eardrum - recently had ear surgery - you need to use for more than four days - excessive earwax remains after use of this product

प्राधिकरण का दर्जा:

OTC monograph final

उत्पाद विशेषताएं

DEBROX- CARBAMIDE PEROXIDE LIQUID
DENISON PHARMACEUTICALS, 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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DEBROX EARWAX REMOVAL AID
DRUG FACTS
ACTIVE INGREDIENT
Carbamide peroxide 6.5% non USP*
*pH differs from USP specifications
PURPOS E
Earwax removal aid
US ES
for occasional use as an aid to soften, loosen, and remove excessive
earwax
ASK A DOCTOR BEFORE USE IF YOU HAVE
ear drainage or discharge
ear pain
irritation or rash in the ear
dizziness
an injury or perforation (hole) of the eardrum
recently had ear surgery
WHEN USING THIS PRODUCT
avoid contact with the eyes
STOP USE AND ASK A DOCTOR IF
you need to use for more than four days
excessive earwax remains after use of this product
KEEP OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.
WARNINGS
DIRECTIONS
FOR USE IN THE EAR ONLY
ADULTS AND CHILDREN OVER 12 YEARS OF AGE:
tilt head sideways
place 5 to 10 drops into ear
tip of applicator should not enter ear canal
keep drops in ear for several minutes by keeping head tilted or
placing cotton in the ear
use twice daily for up to four days if needed, or as directed by a
doctor
any wax remaining after treatment may be removed by gently flushing
the ear with warm water, using
a soft rubber bulb ear syringe
CHILDREN UNDER 12 YEARS: consult a doctor
OTHER INFORMATION
do not store above 25C (77F)
store bottle in the outer carton
product foams on contact with earwax due to release of oxygen. There
may be an associated
“crackling” sound.
keep tip on bottle when not in use
INACTIVE INGREDIENTS
citric acid, flavor, glycerin, propylene glycol, sodium lauroyl
sarcosinate, water
QUESTIONS OR COMMENTS?
call toll-free 1-866-255-5202 (English/Spanish) weekdays
PRINCIPAL DISPLAY PANEL
Debrox
DROPS
Carbamide Peroxide 6.5% Non USP*
Earwax Removal Aid
½ FL OZ (15mL)
®
DEBROX
carb