Ear Wax Treatment
FDA Label NDC 21695-334

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Ear Wax Treatment (NDC 21695-334). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - do not use, ask a doctor before use if you have, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Use

softens, loosens and removes excessive earwax

Otc - Do Not Use

Do not use for more than 4 days

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

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

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

Otc - 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.

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

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

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

Ear Treatment 6.5% (22b7f3d7 7f3e 437f 9326 3eef737edfbb 01)

Ear Treatment 6.5% (22b7f3d7 7f3e 437f 9326 3eef737edfbb 01)

* Please review the disclaimer below.