Rugby® - DailyMed Details

Rugby®

SPL v1

SPL

SPL Set ID 22b7f3d7-7f3e-437f-9326-3eef737edfbb

Route

AURICULAR (OTIC)

Published

Effective Date 2009-12-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Carbamide Peroxide (81.86 mg)

Inactive Ingredients

Water Citric Acid Monohydrate Glycerin Sodium Acid Pyrophosphate Sodium Citrate Propylene Glycol Trolamine

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH FINAL Active Since 2009-10-26

Description

Drug Facts

Purpose

Earwax removal aid

Medication Information

Purpose

Earwax removal aid

Description

Drug Facts

Use

softens, loosens and removes excessive earwax

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if earwax remains longer than 4 days

Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not use for more than 4 days

Directions

FOR USE IN THE EAR ONLY

adults and children over 12 years:

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 tilting head or placing cotton in ear
use twice daily for up to 4 days
remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe

children under 12 years: ask a doctor

Active Ingredient

Carbamide peroxide 6.5%

Other Information

store at room temperature 15° - 30°C (59° - 89°F)
keep in a dry place

Inactive Ingredients

citric acid (anhydrous), glycerin, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate (anhydrous), trolamine

Questions Or Comments?

Call 1-800-645-2158

9am - 5pm ET

Monday - Friday

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Ask A Doctor Before Use If You Have

ear drainage or discharge
ear pain, irritation, rash or are dizzy
an injury or perforation (hole) of the eardrum or if you had ear surgery

Principal Display Panel 15 Ml Carton

COMPARE TO

ACTIVE INGREDIENT IN

DEBROX^®*

Rugby^®

NDC 21695-334-15

Earwax

Treatment

Drops

Carbamide Peroxide 6.5 %

Helps Remove

Excessive Earwax

1/2 fl oz (15 mL)

SATISFACTION GUARANTEED

Rugby

OR YOUR MONEY BACK

Structured Label Content

Use

softens, loosens and removes excessive earwax

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if earwax remains longer than 4 days

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use for more than 4 days

Purpose

Earwax removal aid

Directions

FOR USE IN THE EAR ONLY

adults and children over 12 years:

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 tilting head or placing cotton in ear
use twice daily for up to 4 days
remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe

children under 12 years: ask a doctor

Active Ingredient (Active ingredient)

Carbamide peroxide 6.5%

Other Information (Other information)

store at room temperature 15° - 30°C (59° - 89°F)
keep in a dry place

Inactive Ingredients (Inactive ingredients)

citric acid (anhydrous), glycerin, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate (anhydrous), trolamine

Questions Or Comments? (Questions or comments?)

Call 1-800-645-2158

9am - 5pm ET

Monday - Friday

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

ear drainage or discharge
ear pain, irritation, rash or are dizzy
an injury or perforation (hole) of the eardrum or if you had ear surgery

Principal Display Panel 15 Ml Carton (PRINCIPAL DISPLAY PANEL - 15 mL Carton)

COMPARE TO

ACTIVE INGREDIENT IN

DEBROX^®*

Rugby^®

NDC 21695-334-15

Earwax

Treatment

Drops

Carbamide Peroxide 6.5 %

Helps Remove

Excessive Earwax

1/2 fl oz (15 mL)

SATISFACTION GUARANTEED

Rugby

OR YOUR MONEY BACK

Advanced Ingredient Data

[{"name": "Carbamide Peroxide", "unii": "31PZ2VAU81", "classCode": "ACTIB", "strengthNumerator": "81.86", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Citric Acid Monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Acid Pyrophosphate", "unii": "H5WVD9LZUD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Citrate", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Trolamine", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "softens, loosens and removes excessive earwax", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if earwax remains longer than 4 days", "50567-7": "When using this product avoid contact with the eyes", "50570-1": "Do not use for more than 4 days", "Purpose": "Earwax removal aid", "Directions": "FOR USE IN THE EAR ONLY adults and children over 12 years: 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 tilting head or placing cotton in ear use twice daily for up to 4 days remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe children under 12 years: ask a doctor", "Active ingredient": "Carbamide peroxide 6.5%", "Other information": "store at room temperature 15° - 30°C (59° - 89°F) keep in a dry place", "Inactive ingredients": "citric acid (anhydrous), glycerin, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate (anhydrous), trolamine", "Questions or comments?": "Call 1-800-645-2158 9am - 5pm ET Monday - Friday Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320", "Ask a doctor before use if you have": "ear drainage or discharge ear pain, irritation, rash or are dizzy an injury or perforation (hole) of the eardrum or if you had ear surgery", "PRINCIPAL DISPLAY PANEL - 15 mL Carton": "COMPARE TO ACTIVE INGREDIENT IN DEBROX ® * Rugby ® NDC 21695-334-15 Earwax Treatment Drops Carbamide Peroxide 6.5 % Helps Remove Excessive Earwax 1/2 fl oz (15 mL) SATISFACTION GUARANTEED Rugby OR YOUR MONEY BACK"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:12.735699 · Updated: 2026-03-14T22:52:35.540850