FDA Label for Cortizone 10 Ultra Soothing Itch Relief

View Indications, Usage & Precautions

Cortizone 10 Ultra Soothing Itch Relief 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 Ingredients



Hydrocortisone 1%


Purpose



Anti-Itch


Uses



for the temporary relief of 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

 temporarily relieves external anal and genital itching

 other uses of this product should be only 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, cetearyl alcohol, glycerin, petrolatum, mineral oil, isopropyl palmitate, sodium lauryl sulfate, beeswax, sodium cetearyl sulfate, methylparaben, tocopheryl acetate, propylparaben, propylene glycol, cetyl alcohol, aluminum sulfate, calcium acetate, dextrin, zea mays (corn) oil, cholecalciferol, retinyl palmitate, aloe barbadensis leaf juice, maltodextrin


Principal Display Panel



MAXIMUM STRENGTH
Cortizone 10
ULTRA SOOTHING
ITCH RELIEF
CREAM
1% Hydrocortisone
Anti-Itch Cream
Net wt 1 oz (28 g)


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