Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Choice Laboratories
HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATE 1 g in 100 g
TOPICAL
OTC DRUG
- minor skin irritations - eczema - insect bites - poison ivy - poison oak - poison sumac - soaps - detergents - cosmetics - jewelry - genital - feminine and - anal itching - in the eyes - longer than 1 week unless directed by a physician - for diaper rash - if you have vaginal discharge - more than the recommended daily dosage unless directed by a doctor - in the rectum bu using fingers or any other mechanical device or applicator - the condition persists or gets worse - symptoms clear up and occur again within a few days - you are pregnant or breast feeding
OTC monograph final
HYDROCORTISONE - HYDROCORTISONE ACETATE CREAM CHOICE LABORATORIES _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._ ---------- HYDROCORTISONE CREAM 1% Active Ingredient Purpose Hydrocortisone Acetate 1% Antipruritic (anti-itch) US ES : For temporary relief of; minor skin irritations Itching and rashes due to; eczema insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry and for external itching of; genital feminine and anal itching WARNINGS : FOR EXTERNAL USE ONLY DO NOT USE: in the eyes longer than 1 week unless directed by a physician for diaper rash if you have vaginal discharge more than the recommended daily dosage unless directed by a doctor in the rectum bu using fingers or any other mechanical device or applicator STOP USE AND ASK A PHYSICIAN IF: the condition persists or gets worse symptoms clear up and occur again within a few days you are pregnant or breast feeding KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS : ADULTS AND CHILDREN OVER 2 YEARS OF AGE Apply evenly to affected area no more than 3 or 4 times daily. CHILDREN UNDER 2 YEARS OF AGE Do not use consult a physician ADULTS When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly Gently dry, patting and blotting with bathroom tissue or soft cloth before applying apply externally to the area up to 6 times daily or after each bowel movement OTHER INFORMATION: Store at 20 deg - 25 deg C (68 deg - 77 deg F) Avoid excessive heat and humidity INACTIVE INGREDIENTS: Citric acid, Glycerin, Glycerol sterate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium citrate, Titanium dioxide, Water (purified) PRINCIPAL DISPLAY PANEL Hydrocortisone Cream 1% HYDROCORTISONE hydrocortisone acetate cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC Read the complete document