Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 97f81751-5a8f-4943-9e37-091351867598
Route
TOPICAL
Published
Effective Date 2020-01-18
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, Unspecified Form Sodium Lauryl Sulfate Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-05-27

Description

Carbamide Peroxide, 6.5%

How Supplied

Product: 50090-3893 NDC: 50090-3893-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON


Medication Information

How Supplied

Product: 50090-3893

NDC: 50090-3893-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Description

Carbamide Peroxide, 6.5%

Uses

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

Section 55105-1

Earwax removal aid

warnings

Do not use if you have 

  • eardrainage, discharge, ear pain,irritation
  • rashin the ear,or are dizzy
  • injuryor perforation (hole) of the ear drum or after ear surgery
Active Ingredient

Carbamide Peroxide, 6.5%

other Information
  • Protect from heat and direct sunlight 
  • 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

Carbamide Peroxide 6.5%
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
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.

Structured Label Content

Uses

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

Section 55105-1 (55105-1)

Earwax removal aid

warnings (Warnings)

Do not use if you have 

  • eardrainage, discharge, ear pain,irritation
  • rashin the ear,or are dizzy
  • injuryor perforation (hole) of the ear drum or after ear surgery
How Supplied (HOW SUPPLIED)

Product: 50090-3893

NDC: 50090-3893-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Active Ingredient (Active ingredient)

Carbamide Peroxide, 6.5%

other Information (Other information)
  • Protect from heat and direct sunlight 
  • Keep cap on bottle when not in use.
  • Lot No. and EXP date:  see label, bottom container or box.
inactive Ingredients (Inactive ingredients)

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

Carbamide Peroxide 6.5% (Carbamide Peroxide - 6.5%)
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
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.

Advanced Ingredient Data


Raw Label Data

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