Your browser does not support JavaScript! EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE (PREFERRED PLUS) LIQUID [KINRAY INC]
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EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE (preferred plus) liquid
[Kinray Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredient

Carbamide Peroxide 6.5%

Purpose

Softens and Loosens Wax

Uses

Safely and gently removes ear wax.

Warnings

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 eardrum or after ear surgery, unless directed by a doctor.  For more than four consecutive days.

When using this product: avoid contact with the eyes.

Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

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 ear.  Use twice daily for up to four 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 a soft rubber bulb ear syringe.  Children under 12 years of age:  consult a doctor.

Inactive ingredients

Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil

Ear Wax Removal System

Carton label



EAR WAX REMOVING DROPS  CARBAMIDE PEROXIDE
preferred plus liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61715-031
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (HYDROGEN PEROXIDE) Carbamide Peroxide6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
OXYQUINOLINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-031-741 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34403/15/2013
Labeler - Kinray Inc (012574513)

Revised: 3/2013
 
Kinray Inc

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