mineral oil

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

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 • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoidal tissue and relieves burning • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

Warnings For external and/or intrarectal use only Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • introduction of applicator into the rectum causes additional pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)