Active Ingredient(S)
Hydrocortisone, USP 1%
Hydrocortisone Cream
FDA Label NDC 21922-096
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Encube Ethicals, Inc. for the product Hydrocortisone (NDC 21922-096). 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(s), purpose, use(s), warnings, do not use, when using this product, stop use and ask 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
Use(S)
■temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
■eczema ■ psoriasis ■ insect bites ■ poison ivy, oak, sumac
■detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis
■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
■ in the genital area if you have a vaginal discharge. Consult a doctor.
■ tor the treatment o1 diaper rash. Consult a doctor.
When Using This Product
■ avoid contact with the eyes
■ do not use more than directed unless directed by a doctor
■ do not put directly into the rectum by using fingers or any mechanical device or isopropyl applicator
Stop Use And Ask Doctor If
■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
■ do not begin the use of any other hydrocortisone product unless directed by a doctor
■ rectal bleeding occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
■ for itching of skin irritation, inflammation, and rashes
■ adults and children 2 yearn of age and older: apply to affected area not more than 3 to 4 times daily
■ children under 2 yearn of age: consult a doctor
■ for external anal and genital itching
■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
■ gently dry by paling or blotting with toilet Issue or a soft cloth before application of this product
■ apply to affected area not more than 3 to 4 times daily
■ children under 12 yearn of age: consult a doctor
Other Information
■ store at 15°C to 30°C (59°F to 86°8). Protect from freezing.
■ before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients
cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution* sorbic acid, sorbitan monostearate, stearyl alcohol, white wax
*Contains one or more of these ingredients to adjust pH
Questions Or Comments?
Call 1-833-285-4151
Principal Display Panel
Hydrocortisone Cream USP, 1%
Anti-itch Cream
Net wt. 1 oz (28g)
Carton28g (Carton28g)
Hydrocortisone Cream USP, 1%
Anti-itch Cream
Net wt. 0.5 oz (14g)
Carton14g (Carton14g)
* Please review the disclaimer below.
