OTC Medication Information: Ear Wax Removal Drops

EAR WAX REMOVAL DROPS- carbamide peroxide solution/ drops
GOODSENSE

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.

Active ingredient

Carbamide Peroxide, 6.5%

Purpose

Earwax removal aid

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings

Ask a Doctor before use if you have

  • eardrainage, discharge, ear pain,irritation
  • rash in the ear,or are dizzy
  • injury or perforation (hole) of the ear drum
  • Recently had ear surgery

Stop Use and ask a Doctor if

  • you need to use for more than 4 days
  • execessive ear wax remain after use of this product

When using this product

  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor

Keep out of the 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 of age :
  • 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 the ear.
  • Use twice daily for up to 4 days if needed, or as directed by a doctor.
  • Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.
  • Children under 12 years : consult a doctor.

Other information

  • Protect from heat and direct sunlight
  • product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
  • Keep cap on bottle when not in use.
  • Lot No. and EXP date: see label, bottom container or box.

Inactive ingredients

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Principal Display Panel Bottle Label 0.5 FL OZ

Goodsense NDC 50804-341-51

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Bottle Label 0.5 FL OZ
(click image for full-size original)

Principal Display Panel — Carton label 0.5 FL OZ

Goodsense NDC 50804-341-51

Ear wax Remover Drops

Carbamide Peroxide 6.5%

Ear wax removal aid

0.5 FL OZ ( 15ml)

Principal Display Panel -- Carton label 0.5 FLOZ
(click image for full-size original)

Principal Display Panel — Carton label KIT 0.5 FL OZ

Goodsense NDC 50804-341-61

Ear wax Remover Kit

Carbamide Peroxide 6.5%

Ear wax removal aid

0.5 FL OZ ( 15ml)

Principal Display Panel -- Carton label KIT 0.5 FL OZ
(click image for full-size original)
EAR WAX REMOVAL DROPS
carbamide peroxide — 6.5% solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-341
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE 65 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
ANHYDROUS CITRIC ACID
PROPYLENE GLYCOL
SODIUM CITRATE
SODIUM LAURYL SULFATE
TARTARIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50804-341-51 1 BOTTLE, DROPPER1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 NDC:50804-341-61 1 BOTTLE, DROPPER1 BOTTLE, DROPPER in 1 KIT contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within a CARTON (50804-341-51) and a KIT (50804-341-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 06/05/2019
Labeler — GOODSENSE (076059836)

Revised: 08/2021 GOODSENSE

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.

Terms of Use | Copyright © 2021. All Rights Reserved.