Doloear (wp)(da)

Doloear (wp)(da)
SPL v2
SPL
SPL Set ID 352df636-0469-c33e-e063-6294a90a2224
Route
AURICULAR (OTIC)
Published
Effective Date 2025-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (6.5 g)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-05-15 Until 2027-06-01

Description

.

Purpose

.


Medication Information

Purpose

.

Description

.

Uses

For occasional use as an aid to loosen and remove excessive earwax.

Section 55105-1

Active ingredient

Purpose
Carbamide peroxide 6.5%............... Earwax removal aid

Warnings

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • an injury or perforation (hole) of the ear drum
  • recently had ear surgery
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 wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • children under 12 years of age: consult a doctor
Dist. By/ Por:

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Other Information
  • Store in a cool dry place
  • do not use if clear seal over dropper is torn, broken, or missing
Inactive Ingredients

glycerin, water

Questions Or Comments?

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

When Using This Product

avoid contact with the eyes.

Active Ingredient and Purpose

.

Stop Use and Ask Your Doctor If
  • you need to use for more than 4 days
  • excessive earwax remains after use of this product

Structured Label Content

Uses

For occasional use as an aid to loosen and remove excessive earwax.

Section 55105-1 (55105-1)

Active ingredient

Purpose
Carbamide peroxide 6.5%............... Earwax removal aid

Warnings

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • an injury or perforation (hole) of the ear drum
  • recently had ear surgery
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 wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • children under 12 years of age: consult a doctor
Dist. By/ Por: (Dist. by/ por:)

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Other Information (Other information)
  • Store in a cool dry place
  • do not use if clear seal over dropper is torn, broken, or missing
Inactive Ingredients (Inactive ingredients)

glycerin, water

Questions Or Comments? (Questions or comments?)

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

When Using This Product (When using this product)

avoid contact with the eyes.

Active Ingredient and Purpose

.

Stop Use and Ask Your Doctor If (Stop use and ask your doctor if)
  • you need to use for more than 4 days
  • excessive earwax remains after use of this product

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)