Mineral Oil: Package Insert and Label Information

MINERAL OIL- mineral oil and petrolatum ointment
Rebel Distributors Corp

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 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

Lacri-Lube
(click image for full-size original)

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 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 568 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL
LANOLIN ALCOHOLS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-681-35 3.5 g in 1 TUBE None
2 NDC:21695-681-07 7 g in 1 TUBE None
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 Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 02/2011 Rebel Distributors Corp

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