Quality Choice Earwax Removal Kit

Quality Choice Earwax Removal Kit
SPL v3
SPL
SPL Set ID ba8d71b5-7f1f-44a5-ac5b-1f7ceeb02875
Route
TOPICAL
Published
Effective Date 2014-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Sodium Citrate Sodium Lauryl Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-27

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, looser, and remove excessive earwax

Section 42229-5

*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Distributed by C.D.M.A., Inc.  43157 W. Nine Mile Novi, MI 48376-0995  www.qualitychoice.com  Questions: 248-449-9300

Section 51945-4

Quality Choice Earwax Removal Kit Earwax Removal aid  Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating  Washer Bulb Included  0.5 FL OZ (15mL)

Warnings

For use in the ear only

Directions

FOR USE IN THE EAR ONLY Adults and children over 12 years of age:

Children under 12 years: consult a doctor

  • 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 titled 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
Drug Facts



Questions?

1-800-328-5890

Product Labels

Active Ingredient

Carbamide peroxide 6.5%

Other Information
  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound
  • Do not use if tamper-evident safety seal is broken or missing

Inactive Ingredients

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If
  • You need to use for more than 4 days
  • Excessive earwax remains after use of this product

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 ear drum
  • Recently had ear surgery


Structured Label Content

Uses

for occasional use as an aid to soften, looser, and remove excessive earwax

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Distributed by C.D.M.A., Inc.  43157 W. Nine Mile Novi, MI 48376-0995  www.qualitychoice.com  Questions: 248-449-9300

Section 51945-4 (51945-4)

Quality Choice Earwax Removal Kit Earwax Removal aid  Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating  Washer Bulb Included  0.5 FL OZ (15mL)

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:

Children under 12 years: consult a doctor

  • 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 titled 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
Drug Facts (Drug facts)



Questions?

1-800-328-5890

Product Labels

Active Ingredient (Active ingredient)

Carbamide peroxide 6.5%

Other Information (Other information)
  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound
  • Do not use if tamper-evident safety seal is broken or missing

Inactive Ingredients (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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • You need to use for more than 4 days
  • Excessive earwax remains after use of this product

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 ear drum
  • Recently had ear surgery


Advanced Ingredient Data


Raw Label Data

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