Dg Health Ear Wax Remover Kit 

Dg Health Ear Wax Remover Kit 
SPL v3
SPL
SPL Set ID 4b6fc00f-72d7-4675-9881-b763f27c06e3
Route
TOPICAL
Published
Effective Date 2023-12-07
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 2023-11-01

Description

Carbamide peroxide, 6.5%

Purpose

Ear wax Remover


Medication Information

Purpose

Ear wax Remover

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
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 Carton Label 0.5 Floz 

DG Health

Ear Wax Removal Kit

Carbamide Peroxide 6.5%

0.5 FLOZ (15mL)



Principal Display Panel Bottle Label 0.5 Fl Oz 

DG Health

Ear Wax Removal Kit

Carbamide Peroxide 6.5%

0.5 FLOZ (15mL)


Structured Label Content

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

Ear wax Remover

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 Carton Label 0.5 Floz  (Principal Display Panel- Carton label 0.5 FLOZ )

DG Health

Ear Wax Removal Kit

Carbamide Peroxide 6.5%

0.5 FLOZ (15mL)



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

DG Health

Ear Wax Removal Kit

Carbamide Peroxide 6.5%

0.5 FLOZ (15mL)


Advanced Ingredient Data


Raw Label Data

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