Active Ingredients
Hydrocortisone 1%
Cortizone 10 Fast Acting Itch Relief Cooling Spray
FDA Label NDC 41167-0343
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 Fast Acting Itch Relief Cooling (NDC 41167-0343). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Cortizone 10fast Acting Itch Reliefcooling Spraysoothing Aloe1% Hydrocortisoneanti-itch Spraynet Wt 2.7 Oz (76 G) (Cortizone 10 Cooling Spray 01)
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