国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Leader
OPHTHALMIC
OTC DRUG
Uses - For the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure to wind or sun. - May be used as a protectant against further irritation Stop use and ask a doctor if: - You experience eye pain, changes in vision, continued redness or irritation of the eye. - The condition worsens or persists for more than 72 hours. . Directions • Wash your hands. • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.
OTC monograph final
LEADER LUBRICANT EYE- MINERAL OIL, AND WHITE PETROLATUM OINTMENT LEADER _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._ ---------- LEADER LUBRICANT EYE OINTMENT Active ingredients Purpose Mineral oil 42.5%........................................................ Eye Lubricant White petrolatum 57.3%............................................. Eye Lubricant Uses For the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure to wind or sun. May be used as a protectant against further irritation Warnings For external use only. To avoid contamination, do not touch tip of container to any surface. Keep tube tightly closed. STOP USE AND ASK A DOCTOR IF: You experience eye pain, changes in vision, continued redness or irritation of the eye. The condition worsens or persists for more than 72 hours. . Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800- 222-1222. DIRECTIONS • Wash your hands. • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid. OTHER INFORMATION store away from heat protect from freezing use before expiration date on the tube store at 59°-86° (15°-30°) INACTIVE INGREDIENT lanolin alcohol Directions • Wash your hands. • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid. Leader Lubricant Eye Ointment Principal Display Panel LEADER LUBRICANT EYE mineral oil, and white petrolatum ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:70000-0513 ROUTE OF ADMINISTRATION OPHTHALMIC Leader ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 425 mg in 1 g PETROLATUM (UNII: 4 阅读完整的文件