Premier Value Ear Wax Removal Aid Drops

SPL v6

SPL

SPL Set ID 85ae80c1-2bc2-4c90-9559-63510d03e739

Route

AURICULAR (OTIC)

Published

Effective Date 2019-06-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (0.065 mg)

Inactive Ingredients

Adipic Acid Glycerin Polysorbate 80

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-04-18

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

Directions

FOR USE IN THE EAR ONLY.

▪
Adults and children over 12 years of age:
▪
tilt head sideways
▪
place 5 to 10 drops into ear canal.
▪
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 four 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 of age: consult a doctor.

Active Ingredient

Carbamide Peroxide 6.5%

Other Information

▪
Store at room temperature
▪
Avoid exposing bottle to excessive heat and direct sunlight
▪
Store bottle in the outer carton
▪
Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.
▪
Keep cap on bottle when not in use

Inactive Ingredients

adipic acid, anhydrous glycerin, polysorbate 80.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Premier Value®

NDC 68016-793-15

*COMPARE TO THE ACTIVE INGREDIENT IN DEBROX^® DROPS

EAR WAX REMOVAL AID DROPS KIT

Carbamide Peroxide 6.5%

Ear Wax Removal Aid

•
Safe & Gentle
•
Microfoam Cleansing Action
•
Easy to use Instructions

NET WT 0.5 FL OZ (15 mL)

This kit include soft rubber bulb ear syringe and drops

TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN

IMPORTANT: Keep the carton for future reference on full labeling.

Distributed BY:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox^® Drops.

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

▪
you need to use for more than four days
▪
excessive ear wax remains after use this product

Keep Out of Reach of Children.

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

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 eardrum
▪
recently had ear surgery

Structured Label Content

Uses

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

Purpose

Earwax removal aid

Directions

FOR USE IN THE EAR ONLY.

▪
Adults and children over 12 years of age:
▪
tilt head sideways
▪
place 5 to 10 drops into ear canal.
▪
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 four 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 of age: consult a doctor.

Active Ingredient (Active ingredient)

Carbamide Peroxide 6.5%

Other Information (Other information)

▪
Store at room temperature
▪
Avoid exposing bottle to excessive heat and direct sunlight
▪
Store bottle in the outer carton
▪
Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.
▪
Keep cap on bottle when not in use

Inactive Ingredients (Inactive ingredients)

adipic acid, anhydrous glycerin, polysorbate 80.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Premier Value®

NDC 68016-793-15

*COMPARE TO THE ACTIVE INGREDIENT IN DEBROX^® DROPS

EAR WAX REMOVAL AID DROPS KIT

Carbamide Peroxide 6.5%

Ear Wax Removal Aid

•
Safe & Gentle
•
Microfoam Cleansing Action
•
Easy to use Instructions

NET WT 0.5 FL OZ (15 mL)

This kit include soft rubber bulb ear syringe and drops

TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN

IMPORTANT: Keep the carton for future reference on full labeling.

Distributed BY:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox^® Drops.

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 four days
▪
excessive ear wax remains after use 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 right away at (1-800-222-1222).

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 eardrum
▪
recently had ear surgery

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "0.065", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ADIPIC ACID", "unii": "76A0JE0FKJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For occasional use as an aid to soften, loosen and remove excessive ear wax", "Purpose": "Earwax removal aid", "Directions": "FOR USE IN THE EAR ONLY. ▪ Adults and children over 12 years of age: ▪ tilt head sideways ▪ place 5 to 10 drops into ear canal. ▪ 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 four 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 of age: consult a doctor.", "Active ingredient": "Carbamide Peroxide 6.5%", "Other information": "▪ Store at room temperature ▪ Avoid exposing bottle to excessive heat and direct sunlight ▪ Store bottle in the outer carton ▪ Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound. ▪ Keep cap on bottle when not in use", "Inactive ingredients": "adipic acid, anhydrous glycerin, polysorbate 80.", "Questions or comments?": "1-866-467-2748", "PRINCIPAL DISPLAY PANEL": "Premier Value® NDC 68016-793-15 *COMPARE TO THE ACTIVE INGREDIENT IN DEBROX ® DROPS EAR WAX REMOVAL AID DROPS KIT Carbamide Peroxide 6.5% Ear Wax Removal Aid • Safe & Gentle • Microfoam Cleansing Action • Easy to use Instructions NET WT 0.5 FL OZ (15 mL) This kit include soft rubber bulb ear syringe and drops TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN IMPORTANT: Keep the carton for future reference on full labeling. Distributed BY: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox ® Drops.", "When using this product": "avoid contact with the eyes", "Stop use and ask a doctor if": "▪ you need to use for more than four days ▪ excessive ear wax remains after use this product", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).", "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 eardrum ▪ recently had ear surgery"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:06.589209 · Updated: 2026-03-14T23:04:35.063520