Auro Ear Wax Remover
FDA Label NDC 63736-232

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Auro Ear Wax Remover (NDC 63736-232). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (22mL Tube Carton)

Principal Display Panel (22mL Tube Carton)

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