Label: EAR DROPS MAJOR- carbamide peroxide 6.5% liquid
- NDC Code(s): 0904-6627-35
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 14, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery
When using this product avoid contact with eyes
Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product
Stop use and ask a doctor if you need to use for more than four days • excessive earwax remains after use of this product
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away -
DOSAGE & ADMINISTRATION
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. - INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EAR DROPS MAJOR
carbamide peroxide 6.5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6627 Route of Administration AURICULAR (OTIC) 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 SODIUM STANNATE (UNII: NJ7C1V83KG) GLYCERIN (UNII: PDC6A3C0OX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6627-35 1 in 1 CARTON 10/10/2019 1 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 Drug M014 10/10/2019 Labeler - Major Pharmaceuticals (191427277) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 analysis(0904-6627) , manufacture(0904-6627) , pack(0904-6627) , label(0904-6627)
