FDA Label for Lubricant Eye Pm
View Indications, Usage & Precautions
Lubricant Eye Pm Product Label
The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratories Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
*This product is not manufactured or distributed by Allergan USA, Inc., owner of the registered trademark Refresh P.M.
Distributed by:
Reliable-1 Laboratories LLC
Valley Stream, NY 11580
www.reliable1labs.com
DO NOT USE IF CAP AND NECKRING ARE NOT INTACT
SAVE CARTON FOR COMPLETE DRUG FACTS
Lubricant Eye Ointment P.M. provides soothing night time relief for more intense dry, irritated eyes. Ideal for use at bedtime.
Safe to use as often as needed.
Otc - Active Ingredient
Active ingredients
Mineral Oil 42.5%
White Petrolatum 57.3%
Otc - Purpose
Purpose
Eye lubricant
Indications & Usage
Uses
- For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun.
- May be used as a protectant against further irritation.
Warnings
Warnings
For external use only
Otc - When Using
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after use
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or persists for more than 72 hours
- you experience eye pain, changes in vision, continued redness or irritation of the eye
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- pull down the lower lid of the affected eye
- apply a small amount (1/4 inch) of the ointment to the inside of the eyelid
Storage And Handling
Other information
- store at 15°-25°C (59°-77°F)
- keep tightly closed
- see crimp of tube or carton for Lot Number and Expiration Date
Inactive Ingredient
Inactive ingredient
Lanolin alcohols
Otc - Questions
Questions or comments?
call 516-341-0666, 8:30 - 4:30 pm ET, Monday - Friday
Package Label.Principal Display Panel
Compare to Active Ingredients in Refresh P.M.®*
NDC 69618-060-76
Reliable-1® LABORATORIES
LUBRICANT EYE OINTMENT P.M.
Soothes Irritated, Dry Eyes Overnight
PRESERVATIVE FREE
Sterile
Net Wt. 1/8 OZ (3.5 g)
* Please review the disclaimer below.