EAR WAX REMOVAL DROPS- carbamide peroxide liquid 
Product Quest Mfg

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                                           Purpose
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 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 four
consecutive days.
When using this product • avoid contact with 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

Other information

Protect from heat and direct sunlight.
Keep cap on bottle when not in use

Inactive ingredients

Aloe Barbadensis Leaf Extract,
Chamomilla Recutita (Matricaria) Flower Extract, Glycerin,
Mineral Oil, Oxyquinoline Sulfate, Water.

Questions? 866-483-2846

image description

EAR WAX REMOVAL DROPS 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5118
Route of AdministrationTOPICAL
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
Aloe (UNII: V5VD430YW9)  
CHAMOMILE (UNII: FGL3685T2X)  
Glycerin (UNII: PDC6A3C0OX)  
Mineral Oil (UNII: T5L8T28FGP)  
Oxyquinoline Sulfate (UNII: 61VUG75Y3P)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-5118-11 in 1 CARTON10/05/2011
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/05/2011
Labeler - Product Quest Mfg (927768135)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(64048-5118) , label(64048-5118)

Revised: 8/2018
Document Id: f2c3033a-b17f-4cd6-97c2-d5f4d204da63
Set id: abfbf016-fda2-44a3-8bd7-be5eb9cd8b99
Version: 1
Effective Time: 20180816
 
Product Quest Mfg