OTC Medication Information: Ear Wax Treatment

EAR WAX TREATMENT- carbamide peroxide solution/ drops
Rebel Distributors Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Use

softens, loosens and removes excessive earwax

Warnings

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

When using this product avoid contact with the eyes

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

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%
(click image for full-size original)

EAR WAX TREATMENT
carbamide peroxide solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-334(NDC:0536-3000)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbamide Peroxide (Carbamide Peroxide) Carbamide Peroxide 81.86 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
Citric Acid Monohydrate
Glycerin
Sodium Acid Pyrophosphate
Sodium Citrate
Propylene Glycol
Trolamine
Product Characteristics
Color YELLOW (Colorless to pale yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-334-15 15 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 10/26/2009
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 02/2011 Rebel Distributors Corp

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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