FDA Label for Lubricant Pm
View Indications, Usage & Precautions
Lubricant Pm Product Label
The following document was submitted to the FDA by the labeler of this product Aace Pharmaceuticals, Inc.. 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.
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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
Mineral Oil 42.5% and White Petrolatum 57.3%
Purpose
Lubricant
Uses
- For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind and sun.
- May be used as a protectant against further irritation.
Warnings
- For external use only.
- To avoid contamination, do not touch the tip of container to any surface. Replace cap after using.
Stop Use And Ask A Doctor If
- you feel eye pain.
- changes in vision occur.
- redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Pull down the lower lid of the affected eye and apply a small amount (one fourth inch) of ointment to the inside of the eyelid.
Other Information
- Store away from heat.
- Protect from freezing.
- Use only if tape seals on top and bottom flaps are intact.
- Use before expiration date marked on container.
- Store at 15° to 30°C (59° to 86°F).
RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients
Lanolin Alcohols.
Principal Display Panel
NDC#: 71406-124-35
Compare to Refresh P.M. ® Ointment active ingredients*
Lubricant PM Ointment
Sensitive
Preservative Free
Ointment for Nighttime Dry Eye Relief
Net Wt. 3.5 g (1/8 oz.) Sterile
Distributed By:
AACE Pharmaceuticals, Inc., Fairfield, NJ 07004
www.aacepharma.com
Rev. 00
*This product is not manufactured by Allergan, Inc. distributor of Refresh PM ® Ointment.
* Please review the disclaimer below.