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)
United Exchange Corp
TOPICAL
OTC DRUG
Uses - helps relieve the local itching and discomfort associated with hemorrhoids - temporarily shrinks hemorrhoidal tissue and relieve 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 gets worse or does not get better 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 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
FAMILY CARE HEMORRHOIDAL- MINERAL OIL OINTMENT UNITED EXCHANGE CORP _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._ ---------- FAMILY CARE HEMORRHOIDAL OINTMENT 0.67OZ (WITH APPLICATOR) 515 Active ingredients Purpose Mineral oil 14%.........................................................Protectant Petrolatum 74.9%.....................................................Protectant Phenylephrine HCl 0.25%...................................Vasoconstrictor Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue and relieve 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 use only / 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 a pharmacist before use if you are now taking a prescription drug for high blood pressure or depression When using this product do not use more than the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if rectal bleeding occurs condition gets worse or does not get better within 7 days introduction of applicator into the rectum causes additional pain If pregnant or breast-feeding, ask a physician before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 tube, peel back foil seal when first opening tube, peel back foil seal apply to the affected area up to 4 tim Read the complete document