Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 33442c7e-46dc-4126-abb9-492f94bce5c3
Route
TOPICAL
Published
Effective Date 2013-06-28
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 FINAL Active Since 2012-01-01

Description

Carbamide Peroxide, 6.5%

Purpose

Earwax removal aid


Medication Information

Purpose

Earwax removal aid

Description

Carbamide Peroxide, 6.5%

Uses

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

Section 42229-5

Section 50567-7

When using this product do not get into eyes

Section 50569-3

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • and injury or perforation (hole) of the ear drum
  • recently had ear surgery
Section 51945-4

purpose

Earwax removal aid

warnings

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:  consult a doctor.
Active Ingredient

Carbamide Peroxide, 6.5%

other Information
  • Avoid exposing bottle to excessive heat and direct sunlight.
  • Product foams on contact with earwax due to release of oxygen.  There may be an associated crackling.
  • Keep cap on bottle when not in use.
  • Lot no. and exp. date:  see label, bottom container or box.
inactive Ingredients

Anhydrous Glycerin, Citric Acid, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Keep Out of Reach of Children

In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

stop Use and Ask A Doctor If
  • you need to use of r more than 4 days
  • excessive ear wax remains after use of this product

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • and injury or perforation (hole) of the ear drum
  • recently had ear surgery
Section 51945-4 (51945-4)

purpose (Purpose)

Earwax removal aid

warnings (Warnings)

directions (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:  consult a doctor.
Active Ingredient (Active ingredient)

Carbamide Peroxide, 6.5%

other Information (Other information)
  • Avoid exposing bottle to excessive heat and direct sunlight.
  • Product foams on contact with earwax due to release of oxygen.  There may be an associated crackling.
  • Keep cap on bottle when not in use.
  • Lot no. and exp. date:  see label, bottom container or box.
inactive Ingredients (Inactive ingredients)

Anhydrous Glycerin, Citric Acid, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use of r more than 4 days
  • excessive ear wax remains after use of this product

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)