Label: EAR WAX KIT WELL AT WALGREENS- carbamide peroxide - 6.50% kit
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 21, 2018
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- Active ingredient Purpose
- INDICATIONS & USAGE
WarningsFor 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.
Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Oxyquinoline Sulfate
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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 Marketing Start Date Marketing End Date 1 NDC:0363-3229-07 1 in 1 KIT 08/15/2014 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 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbamide Peroxide (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Carbamide Peroxide 6.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) Glycerin (UNII: PDC6A3C0OX) Oxyquinoline Sulfate (UNII: 61VUG75Y3P) MINERAL OIL (UNII: T5L8T28FGP) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-3230-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 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 Business Operations Product Quest Mfg 927768135 manufacture(0363-3229) , label(0363-3229, 0363-3230)