Label: EAR SYSTEM GNP- carbamide peroxide 6.50% kit
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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.
Drug Label Information
Updated May 4, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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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 eardrum or after ear surgery, unless directed by a doctor.
When using this product avoid contact with eyesStop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
EAR SYSTEM GNP
carbamide peroxide 6.50% kitProduct 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/ dropsProduct 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)
