Country: United States
Language: English
Source: NLM (National Library of Medicine)
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Trifecta Pharmaceuticals USA LLC
TOPICAL
OTC DRUG
Vasoconstrictor Protectant Protectant - 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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful - Bleeding occurs - Condition worsens or does not improve within 7 days - Introduction of applicator into the rectum causes additional pain
OTC monograph final
HEMORRHOIDALOINTMENT- MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI OINTMENT TRIFECTA PHARMACEUTICALS USA 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._ ---------- CVS HEMORRHOIDAL OINTMENT DRUG FACTS ACTIVE INGREDIENT Phenylephrine HCI 0.25% PURPOSE Vasoconstrictor ACTIVE INGREDIENT Mineral Oil 14% PURPOSE Protectant ACTIVE INGREDIENT Petrolatum 74.9% PURPOSE Protectant 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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful WARNINGS FOR EXTERNAL AND/OR INTRARECTAL USE ONLY ASK DOCTOR BEFORE USE IF YOU HAVE heart disease high blood pressure thyroid disease diabetes difficulty urinating due to an enlarged prostate gland ASK DOCTOR BEFORE USE IF YOU ARE presently taking a prescription drug for high blood pressure or depression STOP USE AND ASK 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 doctor 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) 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 with a soft cloth before applying ointment 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 rectum. thoroughly cleanse applicator after each use and replace cover. Also apply ointmen Read the complete document