SuavEar Earwax Removal Aid: Package Insert and Label Information

SUAVEAR EARWAX REMOVAL AID- carbamide peroxide solution/ drops
NEILMED PHARMACEUTICALS INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid

Uses

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

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 eardrum
  • Recently had ear surgery

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

  • You need to use for more than 3 days in a row

Keep this and all drugs out of the reach of children

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

Directions

FOR USE IN THE EAR ONLY

Adults and children 12 years of age:

  • Tilt head sideways
  • Place 5 to 10 drops into the ear, making sure that the tip of the applicator does not enter the earcanal
  • Keep drops in the ear for sevaral minutes, either by using teh included earplugs or keeping the head tilted to the side
  • Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the enclosed soft silicone bulb
  • Use twice daily for upto four days, or as directed by a doctor

Children under 12 years: consult a doctor

Other Information

  • Store bottle in the outer carton
  • Product foams on contact with earwax due to release of oxygen. There may be associated “crackling” sound.
  • Keep cap on bottle when not in use

Inactive Ingredients

Glycerin

Oxyquinoline

Product label : SuavEar Earwax Removal Aid

Suavear
(click image for full-size original)

SUAVEAR EARWAX REMOVAL AID
earwax removal aid solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-312
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE 65 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
OXYQUINOLINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13709-312-01 1 BOTTLE, DROPPER in 1 KIT contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the KIT (13709-312-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 04/22/2021
Labeler — NEILMED PHARMACEUTICALS INC (799295915)
Establishment
Name Address ID/FEI Operations
NEILMED PHARMACEUTICALS INC 799295915 manufacture (13709-312), label (13709-312), pack (13709-312)

Revised: 04/2021 NEILMED PHARMACEUTICALS INC

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