OTC Medication Information: Ear Wax Removal Drops

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.

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

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EAR WAX REMOVAL DROPS carbamide peroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64048-5118
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbamide Peroxide (HYDROGEN PEROXIDE) Carbamide Peroxide 6.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Aloe
CHAMOMILE
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64048-5118-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (64048-5118-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 10/05/2011
Labeler — Product Quest Mfg (927768135)
Registrant — Product Quest Mfg (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg 927768135 manufacture (64048-5118), label (64048-5118)

Revised: 08/2018 Product Quest Mfg

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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