Lubricant PM: Package Insert and Label Information

LUBRICANT PM- mineral oil and petrolatum ointment
Bryant Ranch Prepack

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.

SPL UNCLASSIFIED SECTION

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.

HOW SUPPLIED

NDC: 63629-8897-1: 3.5 g in a TUBE

Lubricant PM Eye Ointment #3.5 g

LUBRICANT PM mineral oil, white petrolatum lubricant eye ointment ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-8897(NDC:71406-124) Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (MINERAL OIL) MINERAL OIL 425 mg in 1 g PETROLATUM (PETROLATUM) PETROLATUM 573 mg in 1 g

Inactive Ingredients Ingredient Name Strength LANOLIN ALCOHOLS

Product Characteristics Color Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63629-8897-1 1 TUBE in 1 CARTON contains a TUBE 1 3.5 g in 1 TUBE This package is contained within the CARTON (63629-8897-1)

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Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 03/19/2020

Labeler — Bryant Ranch Prepack (171714327)

Registrant — Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	REPACK (63629-8897), RELABEL (63629-8897)

Revised: 03/2023 Bryant Ranch Prepack