FDA Label for Auro Ear Wax Remover
View Indications, Usage & Precautions
Auro Ear Wax Remover Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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
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)
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