SPL v1
SPL
SPL Set ID aad7e2cd-cb28-423c-a441-eabe6516d40f
Route
TOPICAL
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-02

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 ear wax.

Warnings

Ask a Doctor before use if you have

  • eardrainage, discharge, ear pain,irritation
  • rash in the ear,or are dizzy
  • injury or perforation (hole) of the ear drum
  • Recently had ear surgery
Purpose 

Earwax Removal Aid 

Active Ingredient

Carbamide Peroxide 6.5%

Other Information 
  • Protect from heat and direct sunlight
  • product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
  • Keep cap on bottle when not in use.
  • Lot No. and EXP date: see label, bottom container or box.
Inactive Ingredients 

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

When Using This Product 
  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor
Stop Use and Ask A Doctor If 
  • you need to use for more than 4 days
  • execessive ear wax remain after use of this product
Keep 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 over 12 years of age:

  • 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

Children under 12 years: consult a doctor.

Principal Display Panel Bottle Label 

Sheffield       

Earwax Removal Aid Drops 

Carbamide Peroxide 6.5%

NET 0.5 FLOZ (15 ml )


Structured Label Content

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings

Ask a Doctor before use if you have

  • eardrainage, discharge, ear pain,irritation
  • rash in the ear,or are dizzy
  • injury or perforation (hole) of the ear drum
  • Recently had ear surgery
Purpose 

Earwax Removal Aid 

Active Ingredient

Carbamide Peroxide 6.5%

Other Information 
  • Protect from heat and direct sunlight
  • product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
  • Keep cap on bottle when not in use.
  • Lot No. and EXP date: see label, bottom container or box.
Inactive Ingredients 

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

When Using This Product  (When Using this Product )
  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor
Stop Use and Ask A Doctor If  (Stop Use and Ask a Doctor if )
  • you need to use for more than 4 days
  • execessive ear wax remain after use of this product
Keep Out of the Reach of Children (Keep 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 (Directions FOR USE IN THE EAR ONLY)

Adults and children over 12 years of age:

  • 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

Children under 12 years: consult a doctor.

Principal Display Panel Bottle Label  (Principal Display Panel -Bottle Label )

Sheffield       

Earwax Removal Aid Drops 

Carbamide Peroxide 6.5%

NET 0.5 FLOZ (15 ml )


Advanced Ingredient Data


Raw Label Data

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