Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Denison Pharmaceuticals, Inc.
AURICULAR (OTIC)
OTC DRUG
Earwax removal aid For occasional use as an aid to soften, loosen and remove excessive ear wax
OTC monograph final
MURINE EAR WAX REMOVAL DROPS- CARBAMIDE PEROXIDE LIQUID DENISON PHARMACEUTICALS, 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._ ---------- MURINE EAR WAX REMOVAL DROPS _DRUG FACTS_ _ACTIVE INGREDIENT_ Carbamide peroxide 6.5% _PURPOSE_ Earwax removal aid _USES_ For occasional use as an aid to soften, loosen and remove excessive ear wax _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE this product for more than 4 days ASK A DOCTOR BEFORE USE if you have ear drainage or discharge, ear pain, irritation, a rash in the ear or are dizzy if you have an injury or perforation (hole) of the eardrum or after ear surgery WHEN USING THIS PRODUCT avoid contact with the eyes STOP USE AND ASK A DOCTOR IF excessive ear wax remains after 4-day treatment with this product NEVER INSERT COTTON SWABS, TOOTHPICKS, HAIRPINS OR OTHER OBJECTS INTO THE EAR CANAL TO REMOVE EARWAX. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor. _DIRECTIONS_ FOR USE IN THE EAR ONLY. Remove any hearing aids before using this product. ADULTS AND CHILDREN OVER 12 YEARS OF AGE: tilt head sideways and place 5 to 10 drops into ear canal. 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. The tip of the ear syringe should not obstruct the flow of fluid leaving the ear. CHILDREN UNDER 12 YEARS OF AGE: consult a doctor. _OTHER INFORMATION_ Murine® Ear Drops foam upon being placed in the ear due to the release of oxygen. This product is not intended to restore hearing Pročitajte cijeli dokument