FDA Label for Astonea
View Indications, Usage & Precautions
Astonea Product Label
The following document was submitted to the FDA by the labeler of this product Astonea Labs Private Limited. 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.
Active Ingredient
Hydrocortisone Acetate USP (1% w/w)
Purpose
Anti-itch
Uses
■ 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 genital, feminine and anal 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
■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage
Ask A Doctor Before Use
■ if you are pregnant or breast feeding
Stop Use And Ask A Doctor If
■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days
Otc - Keep Out Of Reach Of Children
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 to 4 times daily
■ children under 2 years of age■ do not use, consult a doctor
■ Adults
■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying
■ apply externally to the area up to 6 times a daily or after a bowel movement
■ after application discard pad
■ do not flush in toilet
Other Information
■ store at 20-25C (68-77F)
■ avoid excessive heat and humidity
Inactive Ingredients
cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin
Package Label
* Please review the disclaimer below.