EARWAX REMOVAL DROPS EQUATE- carbamide peroxide 6.5% liquid

Earwax Removal Drops by

Drug Labeling and Warnings

Earwax Removal Drops by is a Otc medication manufactured, distributed, or labeled by Walmart, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                        Purpose

Carbamide peroxide  6.5%          Earwax removal aid

PURPOSE

INDICATIONS & USAGE

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

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 ear drum or after ear surgery, unless
directed by a doctor for more than 4 consecutive
days; if excessive earwax remains after use of this
product, consult a doctor

When using this product avoid contact with eyes.
If accidental contact with eyes occurs, flush eyes
with water and consult a doctor

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

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 wax
remaining after the 4-day 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

INACTIVE INGREDIENT

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARWAX REMOVAL DROPS   EQUATE
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-537
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM STANNATE (UNII: NJ7C1V83KG)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-537-01	1 in 1 CARTON	06/05/2017
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	06/05/2017

Labeler - Walmart (051957769)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(49035-537) , label(49035-537)