Cortisone 10 Sensitive Skin Creme Cream
FDA Label NDC 41167-0028

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 Cortisone 10 Sensitive Skin Creme (NDC 41167-0028). 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 purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

Hydrocortisone 1%...........................................................................................................................................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

other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

■ 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 told to do so by a doctor

Stop Use And Ask A Doctor If

condition worsens, or 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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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: do not use, ask a doctor

Inactive Ingredients

water, glycerin, dimethicone, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, isohexadecane, methyl gluceth-20, avena sativa (oat) kernel extract, tocopheryl acetate, magnesium ascorbyl phosphate, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, maltodextrin, ethylhexylglycerin, pentylene glycol, phenoxyethanol, disodium EDTA, dipropylene glycol, 4-t-butylcyclohexanol, benzoic acid, polysorbate 60, sodium citrate, citric acid 

Principal Display Panel

Cortizone 10

Sensitive Skin Crème
Net
wt 2 oz (56 g)

Principal Display Panelcortizone 10sensitive Skin Crèmenet Wt 2 Oz (56 G) (Cortizone 10 Sensitive Skin Creme 01)

Principal Display Panelcortizone 10sensitive Skin Crèmenet Wt 2 Oz (56 G) (Cortizone 10 Sensitive Skin Creme 01)

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