WAXRX EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid

WaxRx Ear Wax Removal Aid Drops by

Drug Labeling and Warnings

WaxRx Ear Wax Removal Aid Drops by is a Otc medication manufactured, distributed, or labeled by DOCTOR EASY MEDICAL PRODUCTS, LLC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Carbamide Peroxide 6.5%

PURPOSE

Carbamide Peroxide 6.5%...................Earwax Removal Aid

INDICATIONS & USAGE

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

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 ear drum
recently had ear surgery

STOP USE

Stop use and ask a doctor if
you need to use for more than 4 days
excessive ear wax remains after use of this product

WHEN USING

When using this product do not get into eyes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose or allergic
reaction, get medical help or contact a Posion Control Center immediately

FOR USE IN THE EAR ONLY

Adults and children over 12 years of age. Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer.

Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician.

STORAGE AND HANDLING

Avoid exposing bottle to excessive heat or direct sunlight.
Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling

Keep cap on bottle when not in use.
Lot no. and exp. date:see Label, bottom contained or box.

INACTIVE INGREDIENT

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

PRINCIPAL DISPLAY PANEL

WaxRx

EAR WAX

REMOVAL

AID DROPS

6.5% Carbamide Peroxide

Safe, Fast Acting

Alcohol Free

0.5 FL OZ (15 ML)

INGREDIENTS AND APPEARANCE

WAXRX EAR WAX REMOVAL AID DROPS 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72724-001
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	6.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72724-001-15	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	12/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	12/12/2018

Labeler - DOCTOR EASY MEDICAL PRODUCTS, LLC (848752523)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(72724-001)