Active Ingredient(S)
Hydrocortisone USP, 1%
Hydrocortisone With Aloe Cream
FDA Label NDC 21922-097
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 With Aloe (NDC 21922-097). 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.
■ for the treatment of 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 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 ether 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 years of age and older: apply to affected area not more than 3 to 4 times daily
■ children under 2 years of age: consult a doctor
■ for external anal and genial itching
■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
■ gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
■ apply to affected area not more than 3 to 4 times daily
■ children under 12 years of age: consult a doctor
Other Information
■ store at 15°C to 30°C (59°F to 86°F). Protect from freezing.
■ before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredient
aloe vera concentrate, cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methyl paraben, 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?
Call 1-833-285-4151
Principal Display Panel
Hydrocortisone Cream USP, 1% with Aloe
Anti-itch Cream
Net wt. 1 oz (28g)
Carton28g (Carton28g)
Hydrocortisone Cream USP, 1% with Aloe
Anti-itch Cream
Net wt. 0.5 oz (14g)
Carton14g (Carton14g)
* Please review the disclaimer below.
