Wax B Gone Ear Wax Removal Drops Solution/ Drops
FDA Label NDC 82498-149

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sigmar, Llc for the product Wax B Gone Ear Wax Removal Drops (NDC 82498-149). 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 active ingredient, purpose, uses, warnings, stop use and ask a doctor if, when using this product, keep out of the reach of children, directions for use in the ear only, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 or rash in the ear
  • dizziness
  • 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

Wax B Gone                NDC 82498-149-15

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml) 

Principal Display Panel Bottle Label 0.5 Fl Oz (790875 Waxbgone Drop Label 3c 3x1.25)

Principal Display Panel Bottle Label 0.5 Fl Oz (790875 Waxbgone Drop Label 3c 3x1.25)

Principal Display Panel - Carton Label 0.5 Fl Oz

Wax B Gone                      NDC 82498-149-15

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)

Principal Display Panel (Carton label 0.5 FLOZ)

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