Label: EAR SYSTEM GNP- carbamide peroxide 6.50% kit
Contains inactivated NDC Code(s)
NDC Code(s): 24385-500-01, 24385-501-07
- Packager: Amerisource Bergen
- 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 May 4, 2016
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- Active ingredient Purpose
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 eardrum or after ear surgery, unless directed by a doctor.
When using this product avoid contact with eyes
Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days
- KEEP OUT OF REACH OF CHILDREN
DirectionsDirections 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.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EAR SYSTEM GNP
carbamide peroxide 6.50% kit
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-501 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24385-501-07 1 in 1 KIT; Type 0: Not a Combination Product 10/15/2003 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 15 mL Part 1 of 1 WAX REMOVAL SYSTEM
carbamide peroxide 6.50% solution/ drops
Product Information Item Code (Source) NDC:24385-500 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 GLYCERIN (UNII: PDC6A3C0OX) OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24385-500-01 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 10/15/2003 Labeler - Amerisource Bergen (007914906) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(24385-500, 24385-501) , label(24385-500, 24385-501)