New Neilmed Suavear Earwax Removal Aid

New Neilmed Suavear Earwax Removal Aid
SPL v2
SPL
SPL Set ID c067f1a4-1f67-3f4d-e053-2a95a90a6095
Route
AURICULAR (OTIC)
Published
Effective Date 2021-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Glycerin Oxyquinoline

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-22

Description

Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid


Medication Information

Purpose

Earwax Removal Aid

Description

Carbamide Peroxide 6.5%

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
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

Active Ingredient

Carbamide Peroxide 6.5%

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

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
Product Label : Suavear Earwax Removal Aid

Keep This and All Drugs Out of the Reach of Children

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


Structured Label Content

Uses

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

Purpose

Earwax Removal Aid

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
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

Active Ingredient

Carbamide Peroxide 6.5%

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

When Using This Product (When using this product)

Avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • You need to use for more than 3 days in a row
Product Label : Suavear Earwax Removal Aid (Product label : SuavEar Earwax Removal Aid)

Keep This and All Drugs Out of the Reach of Children (Keep this and all drugs out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

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