Mineral Oil With Petroleum
FDA Label NDC 0536-1383

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Mineral Oil With Petroleum (NDC 0536-1383). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, stop use, otc - keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredientsPurpose
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

Otc - 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.

Otc - Questions

Questions or Comments? • 888-969-6855

Principal Display Panel

Carton (7223308 Cah Rgb Systane Pm Lubricanteyeointment Box R3 F)

Carton (7223308 Cah Rgb Systane Pm Lubricanteyeointment Box R3 F)

Label (7223308 Cah Rgb Systane Pm Lubricanteyeointment Label R2 F)

Label (7223308 Cah Rgb Systane Pm Lubricanteyeointment Label R2 F)

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