EARWAX TREATMENT DROPS- carbamide peroxide solution

Earwax Treatment Drops by

Drug Labeling and Warnings

Earwax Treatment Drops by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Carbamide peroxide 6.5%

Purpose

Ear wax removal aid

Uses

for occasional use as an aid to

• soften
• loosen
• remove excessive ear wax

Warnings

For use in the ear only

Do not use this product, unless directed by a doctor

• if you have an injury or perforation (hole) of the ear drum
• after ear surgery
• for more than 4 days

Ask your doctor before use if you

• have ear drainage or discharge
• have ear pain, irritation or rash in the ear
• feel dizzy

When using this product avoid contact with the eyes

Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

for adults and children 12 years and over, or as directed by a doctor:

• 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 4 days if needed
• use a soft, rubber bulb ear syringe to gently flush ear with warm water to remove any wax remaining after treatment

Children under 12 years, consult a doctor.

Other information

• store at 20°-25°C
• avoid exposure to excessive heat and direct sunlight
• keep tightly closed
• see carton or label for lot number and expiration date.
• TAMPER-EVIDENT: Do not use this product if the imprinted platic seal around the cap of the bottle is cut, torn, broken or missing.

Inactive Ingredients

citric acid anhydrous, glycerine, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate dihydrate, triethanolamine

Questions or comments?

1-800-645-2158

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Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX®*

Rugby ®

NDC: 68788-6439-1

TAMPER EVIDENT

Earwax
Treatment
Drops

Carbamide Peroxide 6.5%

Helps Remove
Excessive Earwax

1/2 fl oz (15 mL)

Repackaged By: Preferred Pharmaceuticals Inc.

INGREDIENTS AND APPEARANCE

EARWAX TREATMENT DROPS 
carbamide peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6439(NDC: 0536-1012)
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	81.86 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Glycerin (UNII: PDC6A3C0OX)
Sodium Acid Pyrophosphate (UNII: H5WVD9LZUD)
Trisodium Citrate Dihydrate (UNII: B22547B95K)
Propylene Glycol (UNII: 6DC9Q167V3)
Trolamine (UNII: 9O3K93S3TK)

Product Characteristics
Color	YELLOW (Colorloess to pale Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-6439-1	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	07/20/2016

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	REPACK(68788-6439)