מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
REMEDYREPACK INC.
AURICULAR (OTIC)
OTC DRUG
Earwax Removal Aid For occasional use as an aid to soften. loosen and remove excessive earwax.
OTC monograph final
EAR DROPS MAJOR- CARBAMIDE PEROXIDE 6.5% LIQUID REMEDYREPACK INC. _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._ ---------- EAR DROPS MAJOR Carbamide Peroxide 6.5% Earwax Removal Aid For occasional use as an aid to soften. loosen and remove excessive earwax. 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 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. Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water If swallowed, get medical help or contact a Poison Control Center right away. DRUG: Ear DropsMajor Major GENERIC: Carbamide Peroxide 6.5% DOSAGE: LIQUID ADMINSTRATION: AURICULAR (OTIC) NDC: 70518-0524-0 NDC: 70518-0524-1 PACKAGING: 15 mL in 1 BOTTLE OUTER PACKAGING: 1 in 1 CARTON ACTIVE INGREDIENT(S): CARBAMIDE PEROXIDE 6.5g in 100mL INACTIVE INGREDIENT(S): SOD קרא את המסמך השלם