OTC Medication Information: Ear Wax Kit Well At Walgreens

EAR WAX KIT WELL AT WALGREENS- carbamide peroxide — 6.50%
Walgreens

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 — 6.50% Earwax removal aid

​Uses ​ for occasional use as an aid to soften, loosen and remove excessive ear wax

Warnings For external use only

Keep out of reach of the children

If product is swallowed, 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 a soft rubber bulb ear syringe

​Children under 12 years of age: consult a doctor.

Other information

• Protect from heat and direct sunlight • Keep cup on bottle when not in use

Inactive ingredient

Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Oxyquinoline Sulfate

Questions or comments?
1-866-483-2846

image description
(click image for full-size original)
image description
(click image for full-size original)

EAR WAX KIT WELL AT WALGREENS
carbamide peroxide — 6.50% kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3229
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-3229-07 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 15 mL
Part 1 of 1
EAR WAX REMOVAL DROPS WELL AT WALGREENS
carbamide peroxide — 6.50% solution/ drops
Product Information
Item Code (Source) NDC:0363-3230
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 VERA LEAF
CHAMOMILE
Glycerin
Oxyquinoline Sulfate
MINERAL OIL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-3230-01 15 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 08/15/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 08/15/2014
Labeler — Walgreens (008965063)
Registrant — Product Quest Mfg (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg 927768135 manufacture (0363-3229), label (0363-3229), label (0363-3230)

Revised: 02/2018 Walgreens

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.

Terms of Use | Copyright © 2024. All Rights Reserved.