MURINE EAR WAX REMOVAL DROPS- carbamide peroxide liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prestige Brands Holdings, Inc.

INN (International Name):

CARBAMIDE PEROXIDE

Composition:

CARBAMIDE PEROXIDE 0.065 mg in 1 mL

Administration route:

AURICULAR (OTIC)

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

MURINE EAR WAX REMOVAL DROPS- CARBAMIDE PEROXIDE LIQUID
PRESTIGE BRANDS HOLDINGS, 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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MURINE EAR WAX 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
ear wax
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
this product for more than 4 days
ASK A DOCTOR BEFORE USE
if you have ear drainage or discharge, ear pain, irritation, a rash in
the ear or are dizzy
if you have an injury or perforation (hole) of the eardrum or after
ear surgery
WHEN USING THIS PRODUCT
avoid contact with the eyes
STOP USE AND ASK A DOCTOR IF
excessive ear wax remains after 4-day treatment with this product
NEVER INSERT COTTON SWABS, TOOTHPICKS, HAIRPINS OR OTHER OBJECTS INTO
THE EAR CANAL TO REMOVE
EARWAX.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222) right away. If
accidental contact with eyes occurs, flush eyes with water and consult
a doctor.
_DIRECTIONS_
FOR USE IN THE EAR ONLY. Remove any hearing aids before using this
product.
ADULTS AND CHILDREN OVER 12 YEARS OF AGE: tilt head sideways and place
5 to 10 drops into ear canal.
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. The tip of the ear syringe
should not obstruct the flow of fluid
leaving the ear.
CHILDREN UNDER 12 YEARS OF AGE: consult a doctor.
_OTHER INFORMATION_
Murine® Ear Drops foam upon being placed in the ear due to the
release of oxygen.
This product is not intended to restore hearin