Clinere Ear Wax Removal Kit

Clinere Ear Wax Removal Kit
SPL v4
SPL
SPL Set ID d967eac3-0aac-a7ae-e053-2995a90a0e1e
Route
AURICULAR (OTIC)
Published
Effective Date 2023-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (0.065 g)
Inactive Ingredients
Citric Acid Monohydrate Water Propylene Glycol Sodium Lauryl Sulfate Sodium Citrate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-04

Description

Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid


Medication Information

Purpose

Earwax Removal Aid

Description

Carbamide Peroxide 6.5%

Uses

For occassional use as an aid to soften, loosen and remove excess earwax.

Section 50566-9

Stop use and ask a Doctor if

  • you need to use for more than four days
  • excessive earwax remains after use of this product
Warnings

For use in the ear only

Directions

FOR USE IN THE EAR ONLY.

Adults and children over 12 years of age:

  • tilt head sideways and place 5-10 drops into each ear canal.
  • Tip of applicator should not enter ear canal.
  • Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.
  • Use twice daily for up to four days if needed, or as directed by a doctor.
  • Any wax remaining in the ear may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe, or by use of the included Clinere® ear cleaning tool. (See separate directions)

Children under 12 years: Consult a doctor.

Questions?

1-800-328-5890

Weekdays 8:30am -5:00pm CST

Active Ingredient

Carbamide Peroxide 6.5%

Other Information
  • Store at 15° - 30°C (59° - 86°F)
  • Avoid exposing bottle to excessive heat or direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound.
Inactive Ingredients

Anhydrous Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Water

When Using This Product

avoid contact with the eyes.

Keep Out of Reach of Children.

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

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
Clinere® Earwax Removal Kit W/4 Clinere® Ear Cleaners and 1 X 0.5 Fl Oz Carbamide Peroxide Bottle


Structured Label Content

Uses

For occassional use as an aid to soften, loosen and remove excess earwax.

Section 50566-9 (50566-9)

Stop use and ask a Doctor if

  • you need to use for more than four days
  • excessive earwax remains after use of this product
Purpose

Earwax Removal Aid

Warnings

For use in the ear only

Directions

FOR USE IN THE EAR ONLY.

Adults and children over 12 years of age:

  • tilt head sideways and place 5-10 drops into each ear canal.
  • Tip of applicator should not enter ear canal.
  • Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.
  • Use twice daily for up to four days if needed, or as directed by a doctor.
  • Any wax remaining in the ear may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe, or by use of the included Clinere® ear cleaning tool. (See separate directions)

Children under 12 years: Consult a doctor.

Questions?

1-800-328-5890

Weekdays 8:30am -5:00pm CST

Active Ingredient

Carbamide Peroxide 6.5%

Other Information
  • Store at 15° - 30°C (59° - 86°F)
  • Avoid exposing bottle to excessive heat or direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound.
Inactive Ingredients

Anhydrous Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Water

When Using This Product (When using this product)

avoid contact with the eyes.

Keep Out of Reach of Children. (Keep out of reach of Children.)

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

Ask A Doctor Before Use If You Have (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
Clinere® Earwax Removal Kit W/4 Clinere® Ear Cleaners and 1 X 0.5 Fl Oz Carbamide Peroxide Bottle (Clinere® Earwax Removal Kit w/4 Clinere® Ear Cleaners and 1 x 0.5 Fl Oz Carbamide Peroxide Bottle)


Advanced Ingredient Data


Raw Label Data

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