AURO EAR WAX REMOVER- carbamide peroxide liquid

Auro Ear Wax Remover by

Drug Labeling and Warnings

Auro Ear Wax Remover by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Carbamide peroxide 6.5% in anhydrous glycerin

Purpose

Earwax removal aid

Uses

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

Warnings

Flammable, keep away from fire or flame.

FOR EAR USE ONLY

Do not use for more than 4 days

Ask a doctor before use if you have

• ear drainage or discharge
• ear pain, irritation or rash in the ear or are dizzy
• an injury or perforation (hole) of the eardrum
• had ear surgery

When using this product avoid contact with the eyes

Stop use and ask a doctor if excessive earwax remains after use

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older

• 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 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

• recap tube after each use
• store at room temperature
• keep carton for full drug facts

Inactive ingredients

disodium EDTA, disodium laureth sulfosuccinate, isopropyl alcohol, methylparaben, methyl salicylate, propylene glycol, purified water

Questions?

call 1-800-344-7239

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Distributed:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 22mL Tube Carton

DOCTOR
RECOMMENDED
INGREDIENT

AURO®
EAR DROPS

CARBAMIDE PEROXIDE 6.5%
in anhydrous glycerin

EARWAX
REMOVAL AID

SAFE ■ FAST ■ EFFECTIVE
when used as directed

SAFETY SEALED
TUBE TIP

0.75 fl oz. (22mL)

INGREDIENTS AND APPEARANCE

AURO EAR WAX REMOVER 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-232
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Carbamide peroxide (UNII: 31PZ2VAU81) (Carbamide peroxide - UNII:31PZ2VAU81)	Carbamide peroxide	1.44 mL  in 22 mL

Inactive Ingredients
Ingredient Name	Strength
Edetate Disodium (UNII: 7FLD91C86K)
Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)
Isopropyl Alcohol (UNII: ND2M416302)
Methylparaben (UNII: A2I8C7HI9T)
Methyl Salicylate (UNII: LAV5U5022Y)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-232-24	1 in 1 BOX
1		22 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part344	07/01/2010

Labeler - Insight Pharmaceuticals LLC (176792315)