AURALYT- carbamide peroxide liquid 
Menper Distributors, 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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Active Ingredient

Carbamide Peroxide 6.5%...........Earwax removal aid

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, loosen and remove excessive earwax

AVOID CONTACT WITH EYES

Do not use :

  • if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy, consult a doctor 
  • if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
  • for more than 4 days; if excessive ear wax remains after use of this product, consult a doctor.

keep out of reach of children.

if pregnate or breast-feeding

ask a health professional before use.

In case of accidental indegestion, 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 wax remaining after treatment may be removed by gently flushing the ear with warm water, using soft ruber bulb ear syringe.
  • Children under 12 years of age: consult a doctor.

Other information

Store this product between 15° to 30° C (59°-86° F)
Tamper-Evident Feature: Do not use this product if imprinted safety seal over bottle cap is torn, broken, or missing

Inactive ingredients

Cajeput oil, camphor, eucalyptus oil, glycerin, menthol, methlyparaben, phosphoric acid, polysorbate 20, propylene glycol, sodium stannate, water

Questions or comments?

1-800-560-5223 M-F from 9 AM to 4 PM  Eastern.

AuralytAuralyt

AURALYT 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE7.8 mg  in 12 mL
Inactive Ingredients
Ingredient NameStrength
CAJUPUT OIL (UNII: J3TO6BUQ37)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STANNATE (UNII: NJ7C1V83KG)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-311-041 in 1 CARTON01/01/2014
112 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 finalpart34401/01/2014
Labeler - Menper Distributors, Inc (101947166)

Revised: 2/2022
 
Menper Distributors, Inc