Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d
Route
TOPICAL
Published
Effective Date 2023-12-04
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 2019-03-01

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.

purpose

Earwax removal aid

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
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 0.5 Fl Oz

Equate NDC 49035-862-02

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml) 

Principal Display Panel Carton Label 0.5 Fl Oz

Equate       NDC 49035-862-02

Ear wax Remover Drops 

Carbamide Peroxide 6.5%

Ear wax removal aid 

0.5 FL OZ ( 15ml)

Principal Display Panel Carton Label Kit 0.5 Fl Oz

Equate NDC 49035-862-02

Ear wax Remover Kit

Carbamide Peroxide 6.5%

Ear wax removal aid

0.5 FL OZ ( 15ml)


Structured Label Content

Uses

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

purpose (Purpose)

Earwax removal aid

warnings (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
Active Ingredient (Active ingredient)

Carbamide Peroxide, 6.5%

other Information (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 (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 0.5 Fl Oz (Principal Display Panel Bottle Label 0.5 FL OZ)

Equate NDC 49035-862-02

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml) 

Principal Display Panel Carton Label 0.5 Fl Oz (Principal Display Panel - Carton label 0.5 FL OZ)

Equate       NDC 49035-862-02

Ear wax Remover Drops 

Carbamide Peroxide 6.5%

Ear wax removal aid 

0.5 FL OZ ( 15ml)

Principal Display Panel Carton Label Kit 0.5 Fl Oz (Principal Display Panel - Carton label KIT 0.5 FL OZ)

Equate NDC 49035-862-02

Ear wax Remover Kit

Carbamide Peroxide 6.5%

Ear wax removal aid

0.5 FL OZ ( 15ml)


Advanced Ingredient Data


Raw Label Data

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