Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Cardinal Health
AURICULAR (OTIC)
OTC DRUG
Earwax Removal Aid For occasional use to soften, loosen and remove excessive earwax.
OTC monograph final
EARWAX REMOVAL AID- EARWAX REMOVAL AID LIQUID CARDINAL HEALTH _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._ ---------- EARWAX REMOVAL AID ACTIVE INGREDIENT(S) Carbamide Peroxide 6.5% PURPOS E Earwax Removal Aid US E(S ) For occasional use to soften, loosen and remove excessive earwax. WARNINGS WARNING For External Use Only DO NOT USE In the eye for more than 4 days ASK A DOCTOR BEFORE USE IF YOU HAVE ear drainage or discharge pain, irritation or rash in the ear had ear surgery an injury or perforation (hole) in the ear drum STOP USE AND ASK A DOCTOR IF STOP USE AND ASK A DOCTOR IF excessive earwax remains after use KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS FOR USE IN THE EAR ONLY Adults and children 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 my 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 Do not use if imprinted seal on cap is broken or missing. STORAGE Store at controlled room temperature 15 to 30C (59 to 86F) KEEP IN A DRY PLACE PRINCIPAL DISPLAY PANEL Principle display panel: LEADER EAR WAX BOX INACTIVE INGREDIENTS Cardinal Health anhydrous Glycerin EARWAX REMOVAL AID earwax removal aid liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:3720 5-457 ROUTE OF ADMINISTRATION AURICULAR (OTIC) ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CARBAMIDE PERO XIDE (UNII: 31PZ2VAU8 1) (HYDROGEN PEROXIDE - UNII:BBX0 6 0 AN9 V) CARBAMIDE PEROXIDE 6 . Citiți documentul complet