Label: EAR DROPS MAJOR- carbamide peroxide 6.5% liquid
- NDC Code(s): 0904-6627-35
- Packager: Major Pharmaceuticals
- 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 March 16, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
INGREDIENTS AND APPEARANCE
EAR DROPS MAJOR
carbamide peroxide 6.5% liquid
Product 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 final part344 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)