EARWAX REMOVAL AID liquid

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Apothecary Products, LLC

Stjórnsýsluleið:

AURICULAR (OTIC)

Gerð lyfseðils:

OTC DRUG

Ábendingar:

Earwax Removal Aid  For occasional use to soften, loosen and remove excessive earwax.

Leyfisstaða:

OTC monograph final

Vara einkenni

EARWAX REMOVAL AID- EARWAX REMOVAL AID LIQUID
APOTHECARY PRODUCTS, 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._
----------
EARWAX REMOVAL AID
ACTIVE INGREDIENT(S)
Carbamide Peroxide 6.5%
PURPOS E
Earwax Removal Aid
US E(S )
For occasional use to soften, loosen and remove excessive earwax.
WARNINGS
WARNING
For External Use Only
DO NOT USE
In the eye
for more than 4 days
ASK A DOCTOR BEFORE USE IF YOU HAVE
ear drainage or discharge
pain, irritation or rash in the ear
had ear surgery
an injury or perforation (hole) in the ear drum
STOP USE AND ASK A DOCTOR IF
STOP USE AND ASK A DOCTOR IF excessive earwax remains after use
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
Adults and children 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 my be removed by gently flushing the ear
with warm water, using a soft
rubber bulb ear syringe. Children under 12 years of age, consult a
doctor.
OTHER INFORMATION
Do not use if imprinted seal on cap is broken or missing.
STORAGE
Store at controlled room temperature 15 to 30C (59 to 86F)
KEEP IN A DRY PLACE
PRINCIPAL DISPLAY PANEL
Principle display panel:
FLENTS EARWAX REMOVAL AID BOX
INACTIVE INGREDIENTS
anhydrous Glycerin
EARWAX REMOVAL AID
earwax removal aid liquid
Apothecary Products, LLC
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 76 2-453
ROUTE OF ADMINISTRATION
AURICULAR (OTIC)
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CARBAMIDE PERO XIDE (UNII: 31PZ2VAU8 1) (HYDROGEN PEROXIDE -
UNII:BBX0 6 0