WAX OUT PLUS- carbamide peroxide drops solution/ drops 
NEILMED PHARMACEUTICALS INC

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Waxout Plus

Drug Facts Carbamide Peroxide drops
Active Ingredients

Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid

Uses

Use occasionally as an aid to soften, loosen , and remove excessive earwax.

Warnings

Do not use:

When using this product:

Other Information

Inactive Ingredients

Glycerin, Oxyquinoline

Directions for ReUsable Ear Cleaners

For use in the ear only. Make sure to check physical integrity of the tool prior to use. When usingfor teh first time, begin with the COIL tool. Grasp tool comfortably between thumb, index and middle fingers. Direct toward ear. Gently advance tool toward the earcanal and SPIN tool continuously - slowly advancing into the outer portion of canal. Rotate in one direction per insertion. For additional extraction, try the BRISTLE, SCREW or CLUB tools. DO NOT POKE OR JAB INTO EAR. DO NOT FORCIBLY ADVANCE. NOT FOR DEEP CANAL INSERTION. Each person's requirements vary. Impacted earwax should be removed by a health care professional. Check with your physician.

DISINFECTIONS INSTRUCTIONS:

Clean with soap and warm water followed by immersing eartools in isopropyl rubbing alcohol 70%. Use tool when dry.

SUGGESTED USE:

Intended for EAR HYGIENE: Cleaning of debris, itch relief, exfoliation, water extraction and superficial wax around the ear and outer ear canal. Daily or less frequent use may be beneficial.

Directions for Dosing

when Using this product

Keep out of reach of Children

Warnings :

Do not use:

If you have had an allergic reactionto carbamide peroxide or other ingredients in teh dropper bottle.
If you have ear drainage or discharge, ear pain, ear infections, irritation, rash in the ear, or are dizzy. (Please consult a doctor with concerns).
If you have an injury or perforation (hole) of the eardrum or after ear surgery or mastoid surgery, unless directed by a doctor.
More than a twice a week.
For children under 12 years of age.
If you have tubes in your ears.

WaxOut PLus - Box Label

Waxout Plus

WAX OUT PLUS 
carbamide peroxide drops solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-313
Route of AdministrationAURICULAR (OTIC)
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
OXYQUINOLINE (UNII: 5UTX5635HP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-313-011 in 1 KIT10/01/2019
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 DrugM01411/05/2018
Labeler - NEILMED PHARMACEUTICALS INC (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NEILMED PHARMACEUTICALS INC799295915manufacture(13709-313)

Revised: 1/2024
Document Id: 0eb0da5e-0fa4-b442-e063-6394a90a08f4
Set id: cf64f4b8-279c-8c1d-e053-2995a90ac853
Version: 2
Effective Time: 20240111
 
NEILMED PHARMACEUTICALS INC