FDA Label for Cortizone 10 Fast Acting Itch Relief Cooling

View Indications, Usage & Precautions

Cortizone 10 Fast Acting Itch Relief Cooling 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

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


Warnings



For external use only.

Flammable. Keep away from fire or flame. 


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 

■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. 

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ 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. Do not use more than 3 to 4 times daily.

 children under 2 years of age: do not use, ask a doctor.


Other Information



Store between 20° to 25°C (68° to 77°F)


Inactive Ingredients



alcohol denat., aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, ethoxydiglycol, glycerin, hydroxypropyl cellulose, isobutane, menthyl lactate, methyl gluceth-20, PEG-8, water


Principal Display Panel



Cortizone 10
FAST ACTING
ITCH RELIEF
COOLING SPRAY
SOOTHING ALOE
1% Hydrocortisone
Anti-Itch Spray
Net wt 2.7 oz (76 g)


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