Hydrocortisone 1% Cream
FDA Label NDC 83324-047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Hydrocortisone 1% (NDC 83324-047). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, stop using this product and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-Itch
Uses
For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps
● detergents ● cosmetics ● jewelry ● external feminine genital 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:
For the treatment of a diaper rash, consult with doctor
For external genital itching if you have a vaginal discharge, consult doctor
When Using This Product
- Avoid Contact with the eyes
- Do not begin the use of any other hydrocortisone product unless you have consulted a doctor
- For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use and consult a doctor.
- do not put this product into the rectum by using fingers or any medicated device or applicator.
Stop Using This Product And Ask A Doctor If
- conditions worsen
- symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Directions
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use, consult a doctor.
For External and anal itching:
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children: under 12 years of age with external anal itching: consult a doctor.
Inactive Ingredients
Cetyl alcohol, Edetate disodium, Methylparaben, Mineral Oil, Mono-and-di-glycerides, Polysorbate 60, Propylene glycol, Propylparaben, Purified Water, Petrolatum, Sorbitan monostearate
Other Information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Other
Distributed by: CDMA, Inc.
Novi, MI. 48375
www.qualitychoice.com
Questions: 800-935-2362
This product is not manufactured or distrubuted by Valeant Pharamceuticals North America, Inc. distributor of Cortaid.
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