Purpose
Hydrocortisone 1%.........................................................................................................................Anti-Itch
Cortizone 10 Bug Bite Relief Liquid
FDA Label NDC 41167-0337
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 Bug Bite Relief (NDC 41167-0337). 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 purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
■ insect bites ■ poison ivy, oak, sumac ■ eczema ■ psoriasis ■ 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 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 a thin layer 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. (45%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, hydroxyethylcellulose, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, sodium citrate, water
Keep carton as it contains important information.
Principal Display Panel
Cortizone 10
Bug Bite Relief Stick
0.75 fl oz (22.2 mL)
Principal Display Panelcortizone 10bug Bite Relief Stick0.75 Fl Oz (22.2 mL) (Cortizone 10 Bug Bite Relief Stick 01)
* Please review the disclaimer below.
