Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)
SIMPLE PROMISE PTE LTD
TOPICAL
OTC DRUG
• for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
OTC monograph final
SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM- PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE CREAM NUTRIOMO LABS PTE. LTD _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._ ---------- SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM _DRUG FACTS_ _ACTIVE INGREDIENTS_ Phenylephrine HCl 0.25% Pramoxine HCl 1% _PURPOSE_ Vasoconstrictor Local anesthetic _USES_ • for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • 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 DO NOT USE this product if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor. 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. • FOR INTRARECTAL USE: attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. IN CASE OF BLEEDING, CONSULT A DOCTOR PROMPTLY. STOP USE AND ASK A DOCTOR IF • condition worsens or does not improve within 7 days • an allergic reaction develops • the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. 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. _DIRECTIONS_ • ADULTS: when practical, cleanse the affected area by patting or Прочитать полный документ