Cortizone 10 Itch Relief Massaging Rollerball Cream
FDA Label NDC 41167-0338

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 Itch Relief Massaging Rollerball (NDC 41167-0338). 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 be only 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. 

■ if you are allergic to any ingredient in this product

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 

 symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or 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, alcohol denat. (15%), dimethicone, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, ethylhexylglycerin, aloe barbadensis leaf juice, hydroxyacetophenone, glyceryl stearate, C30-45 alkyl cetearyl dimethicone crosspolymer, isohexadecane, acrylates/C10-30 alkyl acrylate crosspolymer, dicetyl phosphate, aminomethyl propanol, steareth-2, steareth-21, polysorbate 60, disodium EDTA, citric acid

Principal Display Panel

Cortizone 10
Itch Relief
Massaging Rollerball 1.5 FL OZ (44.3 mL)

Principal Display Panelcortizone 10 Itch Relief Massaging Rollerball 1.5 Fl Oz (44.3 mL) (Cortizone 10 Itch Relief Massaging Rollerball 01)

Principal Display Panelcortizone 10 Itch Relief Massaging Rollerball 1.5 Fl Oz (44.3 mL) (Cortizone 10 Itch Relief Massaging Rollerball 01)

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