MINERAL OIL WITH PETROLEUM- mineral oil and white petrolatum ointment 
Rugby Laboratories

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.

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Rugby Mineral Oil with Petroleum

Active ingredientsPurpose
Mineral Oil 3%Lubricant
White Petrolatum 94%Lubricant

Uses

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. 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

Inactive ingredient

Lanolin alcohol.

Questions or Comments? • 888-969-6855

PRINCIPAL DISPLAY PANEL

CartonLabel

MINERAL OIL WITH PETROLEUM 
mineral oil and white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1383
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL30 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM940 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1383-911 in 1 CARTON02/27/2023
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/27/2023
Labeler - Rugby Laboratories (079246066)

Revised: 2/2023
Document Id: f5b42952-7aad-0af1-e053-2a95a90ac31d
Set id: f5b4225e-be2c-9f45-e053-2995a90aa28d
Version: 1
Effective Time: 20230227
 
Rugby Laboratories