FDA Label for Cortizone 10 Anti-itch For Diabetics Skin

View Indications, Usage & Precautions

Cortizone 10 Anti-itch For Diabetics Skin 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.

Active Ingredient



Hydrocortisone 1%


Purpose



Anti-itch


Uses



  • temporarily relieves the itching and discomfort associated with minor skin irritations and rashes
  • 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 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, 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: ask a doctor

Inactive Ingredients



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


Principal Display Panel



Cortizone 10®
MAXIMUM STRENGTH
anti-itch lotion for
Diabetics' Skin
fast, lasting relief
to soothe dry, irritated skin
1% Hydrocortisone
Net wt 3.4 oz (96 g)


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