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.

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Drug Facts

Step 1 Ear Wax Removal Drops

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

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EAR WAX KIT WELL AT WALGREENS
carbamide peroxide - 6.50% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-3229

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-3229-07	1 in 1 KIT	08/15/2014

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Carbamide Peroxide (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	Carbamide Peroxide	6.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
Glycerin (UNII: PDC6A3C0OX)
Oxyquinoline Sulfate (UNII: 61VUG75Y3P)
MINERAL OIL (UNII: T5L8T28FGP)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-3230-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	08/15/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	08/15/2014

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(0363-3229) , label(0363-3229, 0363-3230)

Drug Facts Step 1 Ear Wax Removal Drops