Drug Facts

Ear Wax Removal Drops by

Drug Labeling and Warnings

Ear Wax Removal Drops by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EAR WAX REMOVAL DROPS- carbamide peroxide - 6.5% solution/ drops 
REMEDYREPACK INC.

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.

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Drug Facts

Active ingredient

Carbamide Peroxide, 6.5%

Earwax removal aid

Uses

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

Warnings

Do not use if you have 

  • eardrainage, discharge, ear pain,irritation
  • rashin the ear,or are dizzy
  • injuryor perforation (hole) of the ear drum or after ear surgery

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 
  • 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

DRUG: Ear Wax Removal Drops

GENERIC: Carbamide Peroxide - 6.5%

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: TOPICAL

NDC: 70518-0330-0

PACKAGING: 15 mL in 1 BOTTLE, DROPPER

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • CARBAMIDE PEROXIDE 65mg in 1mL

INACTIVE INGREDIENT(S):

  • GLYCERIN
  • SODIUM CITRATE
  • SODIUM LAURYL SULFATE
  • ANHYDROUS CITRIC ACID
  • PROPYLENE GLYCOL
  • TARTARIC ACID

Remedy_Label

EAR WAX REMOVAL DROPS 
carbamide peroxide - 6.5% solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70518-0330(NDC: 57896-339)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TARTARIC ACID (UNII: W4888I119H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70518-0330-01 in 1 CARTON03/17/201704/24/2018
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34403/17/201704/24/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2020
Document Id: 9b26323c-790e-d97f-e053-2a95a90a8c23
Set id: db27d645-4a4f-470e-8bf7-38d4a2be6628
Version: 4
Effective Time: 20200102
 
REMEDYREPACK INC.