MINERAL OIL- lacri-lube ointment

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Mineral Oil 42.5%

White Petrolatum 56.8%

Purpose

Eye lubricant

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

For use as a protectant against further irritation or to relieve dryness or the eye.

Warnings

For external use only.

To avoid contamination, do not touch tip of container to any surface.

Replace cap after using.

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.

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

Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.

Store away from heat. Protect from freezing.

Use before expiration date marked on container.

RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Chlorobutanol and lanolin alcohols.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

MINERAL OIL 
lacri-lube ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-681(NDC:0023-0312)
Route of Administration	OPHTHALMIC

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: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	568 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHLOROBUTANOL (UNII: HM4YQM8WRC)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-681-35	3.5 g in 1 TUBE
2	NDC: 21695-681-07	7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	11/30/2007

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK