Country: United States
Language: English
Source: NLM (National Library of Medicine)
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Winco Foods, LLC
MINERAL OIL
MINERAL OIL 140 mg in 1 g
TOPICAL
OTC DRUG
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 Stop use and ask a doctor if - rectal bleeding occurs - condition worsens or does not improve within 7 days - introduction of applicator into the rectum causes additional pain Directions - adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. - when first opening the tube, peel back foil seal - apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement - intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum -
OTC monograph final
WINCO HEMORRHOIDAL- MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE CREAM WINCO FOODS, LLC _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._ ---------- WINCO HEMORRHOIDAL OINTMENT 2 OZ, ZDP ACTIVE INGREDIENTS PURPOSES Mineral oil 14.0%...................................................................Skin protectant Petrolatum 74.9%...................................................................Skin protectant Phenylephrine HCl 0.25%......................................................Vasoconstrictor 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 FOR EXTERNAL AND/OR INTRARECTAL USE ONLY Ask a doctor before use if you have heart disease high blood pressure thyroid disease difficulty in urination due to enlargement of the prostate gland diabetes 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 rectal 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 (1-800-222-1222) right away. DIRECTIONS adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. when first opening the tube, peel back foil seal app Read the complete document