mineral oil

FDA Drug Profile — Pure and Gentle, Leader Ready to Use Mineral Oil Laxative

mineral oil is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Pure and Gentle, Leader Ready to Use Mineral Oil Laxative. Available dosage form: enema.

Drug Details

Generic Name
mineral oil
Brand Names
Pure and Gentle, Leader Ready to Use Mineral Oil Laxative
Application Number
M007
Sponsor
Medline Industries, LP
NDC Codes
2
Dosage Forms
ENEMA
Routes
RECTAL
Active Ingredients
MINERAL OIL

Indications and Usage

Uses For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.

Warnings

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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.