Label: GOOD NEIGHBOR PHARMACY EAR SYSTEM- carbamide peroxide solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 24385-503-05 - Packager: AmerisourceBergen Drug Corporation
- 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 July 22, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- 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.
•for more than four consecutive days.
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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 ear. Use twice
daily for up to four 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY EAR SYSTEM
carbamide peroxide solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-503 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 OXYQUINOLINE (UNII: 5UTX5635HP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24385-503-05 15 mL in 1 BOTTLE, DROPPER; 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 04/15/2003 Labeler - AmerisourceBergen Drug Corporation (007914906) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(24385-503) , label(24385-503)
