Family Care Earwax Removal Aid Drops 0.5 Oz 639 Zdp

Family Care Earwax Removal Aid Drops 0.5 Oz 639 Zdp
SPL v4
SPL
SPL Set ID 958741f5-47c1-339c-e053-2a95a90a3f5f
Route
AURICULAR (OTIC)
Published
Effective Date 2019-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (0.065 mg)
Inactive Ingredients
Propylene Glycol Citric Acid Monohydrate Sodium Lauroyl Sarcosinate Sodium Stannate Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-22

Description

Active ingredient Purpose Carbamide peroxide 6.5%.................................Ear wax removal


Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • dizziness
  • irritation or rash in the ear
  • recently had ear surgery
  • an injury or perforation (hole) of the eardrum
Indications and Usage

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 ear
  • use twice daily for up to four days if needed, or as directed by a doctor
  • any way 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
Dosage and Administration

Distributed by:

United Exchange Corp.

Cypress, CA 90630

Made in China

Description

Active ingredient Purpose Carbamide peroxide 6.5%.................................Ear wax removal

Section 44425-7

Other information

  • do not store above 25°C (77°F)
  • store bottle in the outer carton
  • product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound
  • 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 (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • you need to use for more than four days
  • excessive earwax remains after use of this product
Section 51727-6

Inactive ingredients

citric acid monohydrate, flavor, glycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, sodium stannate

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

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

Section 55106-9

Active ingredient Purpose

Carbamide peroxide 6.5%.................................Ear wax removal


Structured Label Content

Indications and Usage (34067-9)

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 ear
  • use twice daily for up to four days if needed, or as directed by a doctor
  • any way 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
Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

Cypress, CA 90630

Made in China

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • dizziness
  • irritation or rash in the ear
  • recently had ear surgery
  • an injury or perforation (hole) of the eardrum
Section 44425-7 (44425-7)

Other information

  • do not store above 25°C (77°F)
  • store bottle in the outer carton
  • product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound
  • 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 (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you need to use for more than four days
  • excessive earwax remains after use of this product
Section 51727-6 (51727-6)

Inactive ingredients

citric acid monohydrate, flavor, glycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, sodium stannate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

Active ingredient Purpose

Carbamide peroxide 6.5%.................................Ear wax removal


Advanced Ingredient Data


Raw Label Data

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