Active Ingredient
Hydrocortisone 1%
Hydrocortisone Cream
FDA Label NDC 73141-622
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A2a Integrated Pharmaceuticals, Llc for the product Hydrocortisone (NDC 73141-622). 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, when using this product, stop use and ask a doctor if, 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
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- insect bites
- poison ivy, oak, or sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriarsis
- temporarity 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
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
When Using This Product
- avoid contact with eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- rectal bleeding occurs
- condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked a doctor
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)
Directions
- for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use, ask a doctor
- for external anal and genital itching, adults:
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
Other Information
- store at 20-25°C (68-77°F)
Inactive Ingredients
Cetyl alcohol, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum
Questions Or Comments?
Call 1(800)380-6709
Distributed By:
A2A Integrated Pharmaceuticals
Bowling Green, KY 42101
Carton Label
NDC 73141-622-28
Hydrocortisone Cream 1%
Maximum Strength Anti-Itch Cream
NET WT 1 OZ (28g)
Jar Label
NDC 73141-622-54
Hydrocortisone Cream 1%
Maximum Strength Anti-Itch Cream
NET WT 1LB (454g)
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