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Earwax Treatment Drops by Rugby Laboratories

Medically reviewed on December 5, 2017

Dosage form: solution
Ingredients: Carbamide Peroxide 81.86mg in 1mL
Labeler: Rugby Laboratories
NDC Code: 0536-1012

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.

Earwax Treatment Drops

Drug Facts

Active Ingredient

Carbamide peroxide 6.5%

Purpose

Ear wax removal aid

Uses

for occasional use as an aid to

  • soften
  • loosen
  • remove excessive ear wax

Warnings

For use in the ear only

Do not use this product, unless directed by a doctor

  • if you have an injury or perforation (hole) of the ear drum
  • after ear surgery
  • for more than 4 days

Ask your doctor before use if you
  • have ear drainage or discharge
  • have ear pain, irritation or rash in the ear
  • feel dizzy

When using this product avoid contact with the eyes

Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

for adults and children 12 years and over, or as directed by a doctor:

  • 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 keeping head tilted or placing cotton in ear.
  • use twice daily for up to 4 days if needed
  • use a soft, rubber bulb ear syringe to gently flush ear with warm water to remove any wax remaining after treatment

Children under 12 years, consult a doctor.

Other information
  • store at 20°-25°C
  • avoid exposure to excessive heat and direct sunlight
  • keep tightly closed
  • see carton or label for lot number and expiration date.
  • TAMPER-EVIDENT: Do not use this product if the imprinted platic seal around the cap of the bottle is cut, torn, broken or missing.

Inactive Ingredients

citric acid anhydrous, glycerine, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate dihydrate, triethanolamine

Questions or comments?

1-800-645-2158

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX®*

Rugby ®

NDC 0536-1012-94

TAMPER EVIDENT

Earwax
Treatment
Drops

Carbamide Peroxide 6.5%

Helps Remove
Excessive Earwax

1/2 fl oz (15 mL)

EARWAX TREATMENT DROPS 
carbamide peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1012
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (Hydrogen Peroxide) Carbamide Peroxide81.86 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Anhydrous Citric Acid 
Glycerin 
Sodium Acid Pyrophosphate 
Trisodium Citrate Dihydrate 
Propylene Glycol 
Trolamine 
Product Characteristics
ColorYELLOW (Colorloess to pale Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1012-941 BOTTLE in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34412/10/2014
Labeler - Rugby Laboratories (079246066)
Registrant - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(0536-1012), ANALYSIS(0536-1012), PACK(0536-1012), LABEL(0536-1012)

 
Rugby Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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