GOOD NEIGHBOR PHARMACY EAR SYSTEM- carbamide peroxide 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:

AmerisourceBergen Drug Corporation

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

GOOD NEIGHBOR PHARMACY EAR SYSTEM- CARBAMIDE PEROXIDE SOLUTION/ DROPS
AMERISOURCEBERGEN DRUG CORPORATION
_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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GOOD NEIGHBOR PHARMACY EAR SYSTEM
DRUG FACTS
ACTIVE INGREDIENT
Active ingredient Purpose
Carbamide Peroxide 6.5%..............................Softens & removes
wax
PURPOS E
Softens & removes wax
US ES
For occasional use as an aid to soften, loosen, and remove
excessive ear wax.
WARNINGS
DO NOT USE
•if you have ear drainage or discharge, ear pain, irritation or rash
in the ear, or are dizzy; consult a doctor.
•if you have an injury or perforation (hole) of the eardrum or after
ear surgery, unless directed by a doctor.
•for more than four consecutive days.
WHEN USING THIS PRODUCT
•avoid contact with the eyes.
STOP USE AND ASK A DOCTOR IF
• excessive ear wax remains after
use of this product for four consecutive days.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or
contact a Poison Control Center right away. If accidental contact
with eyes occurs, flush eyes with water and consult a doctor.
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 ear. Use twice
daily for up to four 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 of age: consult a doctor.
OTHER INFORMATION
• Protect from heat and direct sunlight.
• Keep cap on bottle when not in use.
INACTIVE INGREDIENTS
Glycerin, Oxyquinoline.
Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Visit us at
www.goodneighborpharmacy.com
GOOD NEIGHBOR P