EAR WAX REMOVAL DROPS- carbamide peroxide - 6.5% solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Earwax removal aid For occasional use as an aid to soften, loosen and remove excessive ear wax.

Authorization status:

OTC monograph final

Summary of Product characteristics

EAR WAX REMOVAL DROPS- CARBAMIDE PEROXIDE - 6.5% SOLUTION/ DROPS
REMEDYREPACK INC.
_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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_DRUG FACTS_
_ACTIVE INGREDIENT_
Carbamide Peroxide, 6.5%
Earwax removal aid
_USES_
For occasional use as an aid to soften, loosen and remove excessive
ear wax.
_WARNINGS_
DO NOT USE IF YOU HAVE
eardrainage, discharge, ear pain,irritation
rashin the ear,or are dizzy
injuryor perforation (hole) of the ear drum or after ear surgery
WHEN USING THIS PRODUCT
do not use for more than four days
avoid contact with the eyes. If accidental contact with the eyes
occurs, flush eyes with water and
consult a doctor
if excessive earwax remains after the use of this product, consult a
doctor
KEEP 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 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 earwax remaining after treatment may be removed by gently flushing
the ear with warm water,
using a soft rubber bulb ear syringe.
When the ear canal is irrigated, the tip of the ear syringe should not
obstruct the flow of water
leaving the ear canal.
CHILDREN UNDER 12 YEARS : consult a doctor.
_OTHER INFORMATION_
Protect from heat and direct sunlight
Keep cap on bottle when not in use.
Keep cap on bottle when not in use.
Lot No. and EXP date: see label, bottom container or box.
_INACTIVE INGREDIENTS_
Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl
Sulfate, Tartaric Acid
PRINCIPAL DISPLAY PANEL
DRUG: Ear Wax Removal Drops
GENERIC: Carbamide Peroxide - 6.5%
DOSAGE: SOLUTION/