国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
DOCTOR EASY MEDICAL PRODUCTS, LLC
AURICULAR (OTIC)
OTC DRUG
Carbamide Peroxide 6.5%...................Earwax Removal Aid For occasional use as an aid to soften, loosen and remove excessive ear wax Stop use and ask a doctor if • you need to use for more than 4 days • excessive ear wax remains after use of this product Adults and children over 12 years of age. Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer. Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician.
OTC monograph final
WAXRX EAR WAX REMOVAL AID DROPS- CARBAMIDE PEROXIDE LIQUID DOCTOR EASY MEDICAL PRODUCTS, LLC _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._ ---------- Carbamide Peroxide 6.5% Carbamide Peroxide 6.5%...................Earwax Removal Aid For occasional use as an aid to soften, loosen and remove excessive ear wax ASK A DOCTOR BEFORE USE IF YOU HAVE • ear drainage or discharge • ear pain • irritation or rash in the ear • dizziness • an injury or perforation (hole) of the ear drum • recently had ear surgery STOP USE AND ASK A DOCTOR IF • you need to use for more than 4 days • excessive ear wax remains after use of this product WHEN USING THIS PRODUCT do not get into eyes KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose or allergic reaction, get medical help or contact a Posion Control Center immediately FOR USE IN THE EAR ONLY ADULTS AND CHILDREN OVER 12 YEARS OF AGE. Tilt head sideways and place 5-10 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 ears. Flush ear with VERY WARM (body temperature) water using the Wax-Rx Ear Washer. Children under 12, consult a physician. Drops my be used twice daily for up to 4 days or as directed by a physician. • Avoid exposing bottle to excessive heat or direct sunlight. • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling • Keep cap on bottle when not in use. • Lot no. and exp. date:see Label, bottom contained or box. Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid WaxRx EAR WAX REMOVAL AID DROPS 6.5% Carbamide Peroxide Safe, Fast Acting Alcohol Free 0.5 FL OZ (15 ML) WAXRX EAR WAX REMOVAL AID DROPS carbamide peroxide liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC: 阅读完整的文件