SUAVEAR EARWAX REMOVAL AID- earwax removal aid solution/ drops

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

NEILMED PHARMACEUTICALS INC

administration_route:

AURICULAR (OTIC)

prescription_type:

OTC DRUG

therapeutic_indication:

Earwax Removal Aid For occasional use as an aid to soften, loosen and remove excessive earwax - You need to use for more than 3 days in a row

authorization_status:

OTC monograph final

SPC

SUAVEAR EARWAX REMOVAL AID- EARWAX REMOVAL AID SOLUTION/ DROPS
NEILMED PHARMACEUTICALS INC
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NEW NEILMED SUAVEAR EARWAX REMOVAL AID
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
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 3 days in a row
KEEP THIS AND ALL DRUGS OUT OF THE 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
Place 5 to 10 drops into the ear, making sure that the tip of the
applicator does not
enter the earcanal
Keep drops in the ear for sevaral minutes, either by using teh
included earplugs or
keeping the head tilted to the side
Any wax remaining after treatment may be removed by gently flushing
the ear with
warm water, using the enclosed soft silicone bulb
Use twice daily for upto four days, or as directed by a doctor
CHILDREN UNDER 12 YEARS: consult a doctor
OTHER INFORMATION
Store bottle in the outer carton
Product foams on contact with earwax due to release of oxygen. There
may be
associated "crackling" sound.
Keep cap on bottle when not in use
INACTIVE INGREDIENTS
Glycerin
Oxyquinoline
PRODUCT LABEL : SUAVEAR EARWAX REMOVAL AID
NEILMED PHARMACEUTICALS INC
SUAVEAR EARWAX REMOVAL AID
earwax removal aid solution/ drops
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:13709-312
ROUTE OF ADMINISTRATION
AURICULAR (OTIC)
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE -
UNII:BBX060AN9V)
CARBAMIDE
PEROXIDE
65 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
OXYQUINOL