Active Ingredient
Hydrocortisone Acetate USP (1% w/w)
Ancalima Hydrocortisone Cream
FDA Label NDC 73014-3050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ancalima Lifesciences Limited for the product Ancalima Hydrocortisone Cream (NDC 73014-3050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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 white soft paraffin
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