Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Pranicura, LLC
TOPICAL
OTC DRUG
Purposes Protectant Protectant/Anti-Itch Analgesic Active Ingredients Purposes Glycerin 25% …………………………………………………..……..….. Protectant Calamine 20% …………………………………………..…….. Protectant/Anti-Itch Aluminum Hydroxide Gel 5% ……………………………….. Protectant/Anti-Itch Menthol 1% …………………………………………………………..….... Analgesic Uses • Helps relieve the itching and discomfort associated with anorectal disorders • Provides temporary relief from the symptoms of perianal skin irritation • For the temporary relief of itching associated with moist anorectal conditions • For the temporary relief of irritation and burning Do not use unless a prior doctor's diagnosis of anorectal condition has been made Stop use and ask a doctor if ● bleeding occurs ● condition worsens or does not improve within 7 days ● allergic reaction develops ● symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase ● do not put this product into rectum by using fingers or any mechanical device or applicat
OTC monograph final
PRANICURA- GLYCERIN, CALAMINE, ALUMINUM HYDROXIDE, MENTHOL OINTMENT PRANICURA, 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._ ---------- DRUG FACTS ACTIVE INGREDIENTS Glycerin 25% Calamine 20% Aluminum Hydroxide Gel 5% Menthol 1% PURPOS ES Protectant Protectant/Anti-Itch Analgesic Active Ingredients Purposes Glycerin 25% …………………………………………………..……..….. Protectant Calamine 20% …………………………………………..…….. Protectant/Anti-Itch Aluminum Hydroxide Gel 5% ……………………………….. Protectant/Anti-Itch Menthol 1% …………………………………………………………..….... Analgesic Uses • Helps relieve the itching and discomfort associated with anorectal disorders • Provides temporary relief from the symptoms of perianal skin irritation • For the temporary relief of itching associated with moist anorectal conditions • For the temporary relief of irritation and burning For rectal use only Do not use unless a prior doctor’s diagnosis of anorectal condition has been made When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain, other symptoms develop or increase • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product because they interfere with the ability of this product to adhere properly to the skin area DO NOT USE unless a prior doctor's diagnosis of anorectal condition has been made WHEN USING THIS PRODUCT do not exceed the daily recommended dosage unless directed by a doctor STOP USE Preberite celoten dokument