Ear Drops

Ear Drops
SPL v3
SPL
SPL Set ID e8bcf92c-ad32-49d5-e053-2995a90ae0c6
Route
AURICULAR (OTIC)
Published
Effective Date 2022-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-15

Description

Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications

Purpose

Earwax removal aid


Medication Information

Purpose

Earwax removal aid

Description

Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications

Uses

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

Section 42229-5

a+health™

ear drops

carbamide

peroxide 6.5%

earwax

removal aid

SEALED FOR YOUR

PROTECTION.

DO NOT USE IF

SHRINKBAND

ON BOTTLE IS

BROKEN OR MISSING

AT TIME OF

PURCHASE.

*This product is not manufactured

or distributed by Prestige Brands

Inc., owner of the registered

trademark Debrox ®
.

DISTRIBUTED BY:

Bionpharma Inc., Princeton, NJ 08540

L0000592

R0422

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Earwax removal aid

Warnings

Directions

FOR USE IN THE EAR ONLY

Remove any earing aids before use

Adults and children over 12 yrs of age: tilt head to the side and place 10 drops into the ear.

  • Tip of applicator should not enter into the ear canal
  • Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age: Consult a physician.

Do Not Use
  • 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 ear or after ear surgery, unless directed by a doctor
  • for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.
Carton Labeling

*compare to the active ingredient

in Debrox® Ear Drops

twin pack

a+health™

ear drops

carbamide

peroxide 6.5%

earwax removal aid



safe, gentle, non-irritating

easily cleanses ear with

microfoam action

1 fl oz (30mL)

two bottles 0.5 fl oz (15 mL) each

Other Information
  • do not store above 77°F (25°C)
  • store bottle in outer carton
  • product foams on contact with ear was due to the release of oxygen. There may be an associated “crackling” sound.
  • keep cap on bottle when not in use
Active Ingredients

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water.

Questions & Comments?

call toll free 1-888-235-2466

(Mon - Fri 9AM - 5PM EST)

When Using This Product

avoid contact with eyes

Stop use and ask a doctor

  • you need to use for more than four days
  • excessive earwax remains after a four day treatment with this product

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

a+health™

ear drops

carbamide

peroxide 6.5%

earwax

removal aid

SEALED FOR YOUR

PROTECTION.

DO NOT USE IF

SHRINKBAND

ON BOTTLE IS

BROKEN OR MISSING

AT TIME OF

PURCHASE.

*This product is not manufactured

or distributed by Prestige Brands

Inc., owner of the registered

trademark Debrox ®
.

DISTRIBUTED BY:

Bionpharma Inc., Princeton, NJ 08540

L0000592

R0422

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Earwax removal aid

Warnings

Directions

FOR USE IN THE EAR ONLY

Remove any earing aids before use

Adults and children over 12 yrs of age: tilt head to the side and place 10 drops into the ear.

  • Tip of applicator should not enter into the ear canal
  • Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age: Consult a physician.

Do Not Use (Do not use)
  • 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 ear or after ear surgery, unless directed by a doctor
  • for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.
Carton Labeling (Carton labeling)

*compare to the active ingredient

in Debrox® Ear Drops

twin pack

a+health™

ear drops

carbamide

peroxide 6.5%

earwax removal aid



safe, gentle, non-irritating

easily cleanses ear with

microfoam action

1 fl oz (30mL)

two bottles 0.5 fl oz (15 mL) each

Other Information (Other information)
  • do not store above 77°F (25°C)
  • store bottle in outer carton
  • product foams on contact with ear was due to the release of oxygen. There may be an associated “crackling” sound.
  • keep cap on bottle when not in use
Active Ingredients (Active ingredients)

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

Inactive Ingredients (Inactive ingredients)

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water.

Questions & Comments? (Questions & comments?)

call toll free 1-888-235-2466

(Mon - Fri 9AM - 5PM EST)

When Using This Product (When using this product)

avoid contact with eyes

Stop use and ask a doctor

  • you need to use for more than four days
  • excessive earwax remains after a four day treatment with this product

Advanced Ingredient Data


Raw Label Data

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