MINERAL OIL WITH PETROLEUM- mineral oil and white petrolatum ointment

Mineral Oil with Petroleum by

Drug Labeling and Warnings

Mineral Oil with Petroleum by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

PURPOSE

• Active ingredients: Purpose
• Mineral Oil 3%: Lubricant
• White Petrolatum 94%: Lubricant

Uses

• For temporary relief of irritation or dryness in the eye.

Warnings

For use in eyes only. Retain outer carton for full product drug facts.

Do not use if: you are sensitive to any ingredient in this product.

Do not use if bottom ridge of tube is exposed, or if cap of tube is damaged.

Stop use

Stop use and ask a doctor if you are experiencing any of the following:

You experience eye pain or change in vision, continued dryness or irritation of the eye. The condition worsens. Symptoms last longer than 72 hours

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 (1-800-222-1222).

Directions

Wash your hands. Pull down lower lid of the affected eye and apply a small amount (1/4” inch) of ointment to the inside of the eyelid, every 3-4 hours or as directed by doctor.

Other information

• Do not use if bottom ridge of tube cap is exposed. Store at room temperature 15° to 30° C (59° to 86°F) Keep tube tightly closed. See crimp of tube or box for lot number and expiration date.

Inactive ingredient

Lanolin alcohol.

QUESTIONS

Questions or Comments? 888-969-6855

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL OIL WITH PETROLEUM 
mineral oil and white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1383
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	30 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	940 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1383-91	1 in 1 CARTON	02/27/2023
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	02/27/2023

Labeler - Rugby Laboratories (079246066)