FDA Label for Hydrocortisone Cream 1% With Aloe Vera
View Indications, Usage & Precautions
Hydrocortisone Cream 1% With Aloe Vera Product Label
The following document was submitted to the FDA by the labeler of this product Ezricare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient
Hydrocortisone USP 1%
Purpose
Anti-itch
Uses
• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:• eczema • seborrheic dermatitis • psoriasis • Insect bites • poison ivy, poison oak, and poison sumac • cosmetics • jewelry • detergents • soaps • temporarily relieves external anal and genital itching • other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do not use • for the treatment of diaper rash. Ask a doctor. • for external genital itching if you have a vaginal discharge. Ask a doctor. • for external anal itching if rectal bleeding occurs. Consult a doctor promptly.
When using this product • do not get into the eyes • for external anal itching, do not use more than directed, unless told so by a doctor. • do not put into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily. • children under 2 years: ask a doctor • For external anal itching in adults: • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad • gently dry by patting or blotting with toilet tissue or soft cloth before applying • for external anal itching in children under 12 years: ask a doctor
Other Information
• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date
Inactive Ingredients
Aloe Vera Leaf, Cetostearyl Alcohol, Glyceryl Stearate SE, Methylisothiazolinone, Propylene Glycol, Water, Stearic Acid, Trolamine, White Petrolatum
Packaging
* Please review the disclaimer below.
