देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Mckesson Corp. Via Strategic Sourcing Services
TOPICAL
OTC DRUG
for occasional use as an aid to soften, loosen, and remove excessive earwax
OTC monograph final
FOSTER AND THRIVE EARWAX REMOVAL DROPS- CARBAMIDE PEROXIDE SOLUTION/ DROPS MCKESSON CORP. VIA STRATEGIC SOURCING SERVICES _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._ ---------- FOSTER & THRIVE EARWAX 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 earwax _WARNINGS_ FOR USE IN THE EAR ONLY ASK A DOCTOR BEFORE USE IF YOU HAVE ear drainage or discharge irritation or rash in the ear dizziness an injury or perforation (hole) of the ear drum recently had ear surgery WHEN USING THIS PRODUCT avoid contact with the eyes STOP USE AND ASK A DOCTOR IF you need to use for more than 4 days excessive earwax remains after use of this product KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away. _DIRECTIONS_ FOR USE IN THE EAR ONLY ADULTS AND CHILDREN OVER 12 YEARS OF AGE: Tilt head sideways and places 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: consult a doctor _OTHER INFORMATION_ Avoid exposing bottle to excessive heat and direct sunlight Store bottle in the outer carton Do not store above 25°C (77°F) Keep cap on bottle when not in use Product foams on contact with earwax due to release of oxygen. There may be an associated cracklig sound Do not use if tamper-evident safety seal is broken or missing _INACTIVE INGREDIENTS_ anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water _QUESTIONS?_ 833-3 पूरा दस्तावेज़ पढ़ें