Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 0ef2be5b-cc39-48ae-b5c5-e787464dea08
Route
AURICULAR (OTIC)
Published
Effective Date 2012-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Glycerin Oxyquinoline

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-08-24

Description

Drug Facts: Active ingredient: CARBAMIDE PEROXIDE


Medication Information

Warnings and Precautions

Warnings:

Do not use:

If you have had an allergic reaction to carbamide peroxide.

If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor

If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor

For more than four consecutive days

When using this product:

void contact with the eyes

Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.

Dosage and Administration

Place 5 to 10 drops of 6.5% carbamide peroxide solution into e

Description

Ear Wax Removal Complete System

Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax.

The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL).



Section 44425-7

Avoid exposing bottle to excessive heat and direct sunlight. Keep cap on bottle when not in use.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Section 50566-9

Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days

Section 50567-7

When using this product:



    * Avoid contact with the eyes

Section 50569-3

Children under 12 years of age: consult a doctor.

Section 50570-1

Do not use:



    * If you have had an allergic reaction to Carbamide Peroxide.

    * If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor

    * If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor

    * For more than four consecutive days

Section 51727-6

Inactive Ingredients: Glycerin, Oxyquinoline, Aloe Barbadensis, Chamomile

Section 51945-4

Section 55105-1

Softens ear wax. Ear wax removal drops

Section 55106-9

Drug Facts:

Active ingredient: CARBAMIDE PEROXIDE



Ear Wax Removal Drops Directions

Step 1 Ear Wax Removal Drops 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 enclosed ear plugs in ear.
  • Use twice daily for upto 4 days if needed or as directed by a doctor.
  • Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter.
  • Children under 12 years of age: consult a doctor.

Clearcanal Earwax Removal Kit Product Label


Structured Label Content

Dosage and Administration (34068-7)

Place 5 to 10 drops of 6.5% carbamide peroxide solution into e

Warnings and Precautions (34071-1)

Warnings:

Do not use:

If you have had an allergic reaction to carbamide peroxide.

If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor

If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor

For more than four consecutive days

When using this product:

void contact with the eyes

Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.

Description (34089-3)

Ear Wax Removal Complete System

Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax.

The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL).



Section 44425-7 (44425-7)

Avoid exposing bottle to excessive heat and direct sunlight. Keep cap on bottle when not in use.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Section 50566-9 (50566-9)

Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days

Section 50567-7 (50567-7)

When using this product:



    * Avoid contact with the eyes

Section 50569-3 (50569-3)

Children under 12 years of age: consult a doctor.

Section 50570-1 (50570-1)

Do not use:



    * If you have had an allergic reaction to Carbamide Peroxide.

    * If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor

    * If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor

    * For more than four consecutive days

Section 51727-6 (51727-6)

Inactive Ingredients: Glycerin, Oxyquinoline, Aloe Barbadensis, Chamomile

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Softens ear wax. Ear wax removal drops

Section 55106-9 (55106-9)

Drug Facts:

Active ingredient: CARBAMIDE PEROXIDE



Ear Wax Removal Drops Directions

Step 1 Ear Wax Removal Drops 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 enclosed ear plugs in ear.
  • Use twice daily for upto 4 days if needed or as directed by a doctor.
  • Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter.
  • Children under 12 years of age: consult a doctor.

Clearcanal Earwax Removal Kit Product Label (ClearCanal Earwax Removal Kit_Product Label)


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