drug facts

drug facts
SPL v1
SPL
SPL Set ID b6e3ad1c-5134-49f2-8664-534635b9eec3
Route
topical
Published
Effective Date 2020-03-02
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 2020-03-02

Description

Carbamide Peroxide, 6.5%


Medication Information

Uses

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

Description

Carbamide Peroxide, 6.5%

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.
  •  
    NDC 68788-7496-01 1 Bottle .5FL OZ

Relabeled by Preferred Pharmaceuticals, Inc.

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
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

Preferred Plus Pharmacy

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

  •  
    NDC: 68788-7498-01 Bottle .5 FL OZ

Relabeled by Preferred Pharmaceuticals, Inc.


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
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.
  •  
    NDC 68788-7496-01 1 Bottle .5FL OZ

Relabeled by Preferred Pharmaceuticals, Inc.

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
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)

Preferred Plus Pharmacy

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

  •  
    NDC: 68788-7498-01 Bottle .5 FL OZ

Relabeled by Preferred Pharmaceuticals, Inc.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)