family wellness-earwax removal kit, earwax & bulb

family wellness-earwax removal kit, earwax & bulb
SPL v3
SPL
SPL Set ID 26ebf208-4710-4af2-aa2d-b2040b85cf85
Route
auricular (otic)
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrogen peroxide (65 mg)
Inactive Ingredients
anhydrous citric acid glycerin propylene glycol sodium citrate sodium lauryl sulfate water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-11-01
Purpose

Earwax removal aid

Description

Carbamide peroxide 6.5%

Medication Information

Warnings

For use in the ear only

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Purpose

Earwax removal aid

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 flusing the ear with warm water, using a soft rubber bulb ear syringe

Children under 12 years:consult a doctor

Other Information
  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Do not store above 25°C (77°F)
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing
Inactive Ingredients

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Description

Carbamide peroxide 6.5%

Questions?

1-800-328-5890

Drug Facts

Package Labeling:

Active Ingredients

Carbamide peroxide 6.5%

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If:
  • you need to use for more than 4 days
  • excessive earwax remains after use of this product
Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Structured Label Content

Warnings

For use in the ear only

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Purpose

Earwax removal aid

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 flusing the ear with warm water, using a soft rubber bulb ear syringe

Children under 12 years:consult a doctor

Other Information (Other information)
  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Do not store above 25°C (77°F)
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

1-800-328-5890

Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Carbamide peroxide 6.5%

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • you need to use for more than 4 days
  • excessive earwax remains after use of this product
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:39.020872 · Updated: 2026-03-14T23:07:47.363489