Cortizone 10 For Psoriasis Lotion
FDA Label NDC 41167-0341

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 For Psoriasis (NDC 41167-0341). 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 ingredient, 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

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves the itching and discomfort associated with minor skin irritations and rashes
  • other uses of this product should only be used under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • 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

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

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 not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Inactive Ingredients

water, glycerin, petrolatum, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, glyceryl stearate, stearyl alcohol, isohexadecane, methyl gluceth-20, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter extract, avena sativa (oat) kernel extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, ceramide NP, ceramide NS, ceramide EOS, ceramide EOP, ceramide AP, caprooyl phytosphingosine, caprooyl sphingosine, magnesium ascorbyl phosphate, tocopheryl acetate, maltodextrin, polysorbate 60, phenoxyethanol, disodium EDTA, dipropylene glycol, ceteareth-25, cholesterol, behenic acid, pentylene glycol, methylparaben, 4-t-butylcyclohexanol, citric acid, sodium citrate

Principal Display Panel

Cortizone 10®
MAXIMUM STRENGTH
anti-itch lotion for
Psoriasis
1% Hydrocortisone
net wt 3.4 oz (96 g)

Cortizone 10®maximum Strength Anti-itch Lotion Forpsoriasis1% Hydrocortisonenet Wt 3.4 Oz (96 G) (Cortizone 10 For Psoriasis 01)

Cortizone 10®maximum Strength Anti-itch Lotion Forpsoriasis1% Hydrocortisonenet Wt 3.4 Oz (96 G) (Cortizone 10 For Psoriasis 01)

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