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)
FRONT PHARMACEUTICAL PLC
TOPICAL
OTC DRUG
Purposes Protectant Protectant Vasoconstrictor •helps relieve the local itching and discomfort associated with hemorrhoids. Uses •Temporarily shrinks hemorrhoid tissue and relieves burning. •Temporarily provides a coating for relief of anorectal burning. •Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
OTC monograph final
FAMILY WELLNESS- MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL OINTMENT FRONT PHARMACEUTICAL PLC ---------- ACTIVE INGREDIENTS (IN EACH GRAM) Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25% PURPOSES Protectant Protectant Vasoconstrictor •helps relieve the local itching and discomfort associated with hemorrhoids. USES •Temporarily shrinks hemorrhoid tissue and relieves burning. •Temporarily provides a coating for relief of anorectal burning. •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 •diabetes •trouble urinating due to an enlarged prostate gland ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE presently taking a prescription drug for high blood pressure. STOP USE AND ASK A DOCTOR IF •bleeding occurs •condition worsens or does not improve within 7 days. •introduction of the applicator into the rectum causes additional pain. , ask a health professional before use. IF PREGNANT OR BREAST-FEEDING If swallowed, get medical help or contact a Poison Control Center right KEEP OUT OF REACH OF CHILDREN. away. DIRECTIONS Adults and children 12 years of age and older for topical use: •clean the affected area, and pat or dab dry before applying ointment. •apply to the affected area up to 4 times daily, especially after each bowel movement. For intrarectal use: •attach included applicator to tube. •lubricate applicator tip and gently insert into rectum •thoroughly clean applicator after each use, and replace cover Children under 12 years of age: ask a doctor before use. store at room temperature 68° - 77° F (20°-25° C). OTHER INFORMATION beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, INACTIVE INGREDIENTS methylparaben, propylparaben, stearyl alcohol 1-800-639-3803 Weekdays 9 AM to 4 PM EST QUESTIONS? FAMILY WELLNESS mineral oil, petrolatum, phenylephrine hcl ointment PRODUCT Read the complete document