WAXRX EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid 
DOCTOR EASY MEDICAL PRODUCTS, LLC

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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Carbamide Peroxide 6.5%

Carbamide Peroxide 6.5%...................Earwax Removal Aid

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

Ask a doctor before use if you have
• ear drainage or discharge

• ear pain

• irritation or rash in the ear
• dizziness

• an 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
• excessive ear wax remains after use of this product

When using this product do not get into eyes

Keep out of reach of children. In case of accidental overdose or allergic
reaction, get medical help or contact a Posion Control Center immediately

FOR USE IN THE EAR ONLY

Adults and children over 12 years of age. Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer.

Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician.

• Avoid exposing bottle to excessive heat or direct sunlight.
• Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling

• Keep cap on bottle when not in use.
• Lot no. and exp. date:see Label, bottom contained or box.

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

WaxRx

EAR WAX

REMOVAL

AID DROPS

6.5% Carbamide Peroxide

Safe, Fast Acting

Alcohol Free

0.5 FL OZ (15 ML)

WaxRx Drops

WAXRX EAR WAX REMOVAL AID DROPS 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72724-001
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TARTARIC ACID (UNII: W4888I119H)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72724-001-1515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34412/12/2018
Labeler - DOCTOR EASY MEDICAL PRODUCTS, LLC (848752523)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(72724-001)

Revised: 12/2018
Document Id: 7e08cd86-7ae5-7d12-e053-2991aa0a4cba
Set id: 7e08cd86-7ae4-7d12-e053-2991aa0a4cba
Version: 1
Effective Time: 20181212
 
DOCTOR EASY MEDICAL PRODUCTS, LLC