Purpose
Hydrocortisone 1%...........................................................................................................................................Anti-itch
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Cortisone 10 Sensitive Skin Creme (NDC 41167-0028). 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.
Hydrocortisone 1%...........................................................................................................................................Anti-itch
■ temporarily relieves 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 only be under the advice and supervision of a doctor
For external use only
■ for the treatment of diaper rash. Consult a doctor.
■ avoid contact with the eyes
■ do not use more than directed unless told to do so by a doctor
■ condition worsens, or 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
If swallowed, get medical help or contact a Poison Control Center right away.
■ 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: do not use, ask a doctor
water, glycerin, dimethicone, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, isohexadecane, methyl gluceth-20, avena sativa (oat) kernel extract, tocopheryl acetate, magnesium ascorbyl phosphate, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, maltodextrin, ethylhexylglycerin, pentylene glycol, phenoxyethanol, disodium EDTA, dipropylene glycol, 4-t-butylcyclohexanol, benzoic acid, polysorbate 60, sodium citrate, citric acid
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