FDA Label for Cortizone 10 Itch Relief Massaging Rollerball

View Indications, Usage & Precautions

Cortizone 10 Itch Relief Massaging Rollerball Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


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