Active Ingredient
Hydrocortisone 1%
Cortizone-10 Soothing Aloe Creme Cream
FDA Label NDC 41167-0021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Cortizone-10 Soothing Aloe Creme (NDC 41167-0021). 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 ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics
■ soaps ■ seborrheic dermatitis
■ temporarily relieves external anal and genital itching
■ other uses of this product should only be 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
■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
■ rectal bleeding occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center 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: ask a doctor
■ for external anal and genital itching, adults:
■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly
■ gently dry by patting or blotting with toilet tissue or a 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
Inactive Ingredients
aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water
Principal Display Panel
MAXIMUM STRENGTH
Cortizone-10
SOOTHING ALOE CRÈME
1% Hydrocortisone Anti-Itch Crème
Net wt 1 oz (28 g)
Maximum Strengthcortizone-10soothing Aloe CrÈme1% Hydrocortisone Anti-itch Crèmenet Wt 1 Oz (28 G) (Cortizone 10 Soothing Aloe Creme 01)
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