Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990), POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)
KC Pharmaceuticals, Inc.
OPHTHALMIC
OTC DRUG
Purposes Polyvinyl alcohol ......Lubricant Povidone.....................Lubricant Uses • for use as a protectant against further irritation or to relieve dryness of the eye • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
OTC monograph final
ARTIFICIAL TEARS- POLYVINYL ALCOHOL, POVIDONE SOLUTION/ DROPS KC 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._ ---------- _ACTIVE INGREDIENTS_ Polyvinyl alcohol 0.5% Povidone 0.6% _PURPOSES_ Polyvinyl alcohol ......Lubricant Povidone.....................Lubricant _USES_ • for use as a protectant against further irritation or to relieve dryness of the eye • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun _WARNINGS_ For external use only _DO NOT USE THIS PRODUCT IF_ • solution changes color or becomes cloudy _WHEN USING THIS PRODUCT_ • remove contact lens before using • to avoid contamination, do not touch tip of container to any surface • replace cap after using. Keep container tightly closed. _STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE_ • eye pain • changes in vision • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours KEEP OUT OF THE REACH OF CHILDREN. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. _DIRECTIONS_ instill 1 or 2 drops in the affected eye(s) as needed _OTHER INFORMATION_ • store at 15°-30°C (59°-86°F) _INACTIVE INGREDIENTS_ benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic ARTIFICIAL TEARS polyvinyl alcohol, povidone solution/ drops PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:556 51-0 0 8 ROUTE OF ADMINISTRATION OPHTHALMIC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 ) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59 J9 9 0 ) POLYVINYL ALCOHOL, UNSPECIFIED 5 mg in 1 mL P Прочетете целия документ