Ear Wax Treatment description, usages, side effects, indications, overdosage, supplying and lots more!

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Ear Wax Treatment

Rugby Laboratories Inc.

Rugby Earwax Treatment Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Ear Wax Treatment 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

PRINCIPAL DISPLAY PANEL - 15 mL Carton

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX®*

Rugby®
NDC 0536-3000-94

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 Wax Treatment

Ear Wax Treatment

Carbamide Peroxide SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-3000
Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE 81.86 mg

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)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3000-94 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part344 2009-10-26


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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