TECH CARE EARWAX REMOVAL DROPS- carbamide peroxide solution/ drops

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Warner Tech-care Products, LLC

Toedieningsweg:

AURICULAR (OTIC)

Prescription-type:

OTC DRUG

therapeutische indicaties:

for occasional use as an aid to soften, loosen, and remove excessive earwax

Autorisatie-status:

OTC monograph final

Productkenmerken

TECH CARE EARWAX REMOVAL DROPS- CARBAMIDE PEROXIDE SOLUTION/ DROPS
WARNER TECH-CARE PRODUCTS, LLC
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TECH CARE EARWAX REMOVAL DROPS
_DRUG FACTS_
_ACTIVE INGREDIENT_
Carbamide peroxide 6.5%
_PURPOSE_
Earwax removal aid
_USES_
for occasional use as an aid to soften, loosen, and remove excessive
earwax
_WARNINGS_
FOR USE IN THE EAR ONLY
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 ear drum
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 4 days
excessive earwax remains after use of this product
KEEP OUT OF REACH OF CHILDREN.
If swallowed get medical help or contact a Poison Control Center right
away.
_DIRECTIONS_
FOR USE IN THE EAR ONLY
ADULT AND CHILDREN OVER 12 YEARS OF AGE:
Tilt head sideways and 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 4 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_
Avoid exposing bottle to excessive heat and direct sunlight
Store bottle in the outer carton
Keep cap on bottle when not in use
Product foams on contact with earwax due to release of oxygen. There
may be an
associated cracking sound.
Do not use if tamper-evident safety seal is broken or missing
_INACTIVE INGREDIENTS_
anhydrous citric acid, glycerin, propylene glycol, sodium citrate,
sodium lauryl sulfate,
water
_QUESTIONS?_
1-800-328-4757
PACKAGE LABELING:
TECH CARE EARWAX REMOVAL DROPS
carbamide peroxide solution/ drops
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69428-002
ROUTE OF ADMINISTRATION
AURICULAR (OTIC)
Warner Tech-care Products, LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
IN