Cortizone 10 Intensive Healing Itch Relief Cream
FDA Label NDC 41167-0023

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 Intensive Healing Itch Relief Cream (NDC 41167-0023). 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.

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

eczema psoriasispoison 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

water, glycerin, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-2, steareth-21, magnesium ascorbyl phosphate, chamomilla recutita (matricaria) flower extract, hydrolyzed jojoba esters, tocopheryl acetate, niacinamide, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, dimethicone, glyceryl stearate, hydroxyacetophenone, methyl gluceth-20, menthyl lactate, propylene glycol, ethylhexylglycerin, PPG-12/SMDI copolymer, disodium EDTA, beta-glucan

Principal Display Panel

Cortizone 10
Intensive Healing
Itch Relief
Cream
Net wt 1 oz (28 g)

Principal Display Panelcortizone 10intensive Healingitch Reliefcreamnet Wt 1 Oz (28 G) (Cortizone 10 Intensive Healing Itch Relief Cream 01)

Principal Display Panelcortizone 10intensive Healingitch Reliefcreamnet Wt 1 Oz (28 G) (Cortizone 10 Intensive Healing Itch Relief Cream 01)

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