Cortizone 10 Intensive Healing For Eczema Lotion
FDA Label NDC 41167-0331

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 Intensive Healing For Eczema (NDC 41167-0331). 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, 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

Active Ingredient:

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

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

Other Information

  • contents filled by weight, not volume

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serata gum, butyrospermum parkii (shea) butter extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, disodium EDTA, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, retinyl palmitate, sodium citrate, tocopheryl acetate, water, singiber officinale (ginger) root extract (283-035) 

*Clinically proven to moisturize for 24 hours

**Refers to the ingredient hydrocortisone

†Contains 7 healing moisturizers and vitamins A, C & E

Principal Display Panel

NEW!

Fast, Lasting

Itch Relief

MAXIMUM STRENGTH

Cortizone-10®

INTENSIVE HEALING

LOTION†

ECZEMA

And Itchy, Dry Skin

Dermatologist

Recommended

  • 7 intensive moisturizers
  • Clinical strength*

    •  With

    Restora TM 

    Botanical &

    Vitamin Complex

    1% Hydrocortisone Anti-Itch Lotion

    DOCTORS

    #1 ITCH MEDICINE

    RECOMMEND

    Net wt 3.5 oz (99g)

    Principal Display Panel (Cortizone 10 Intensive Healing For Eczema 01)

    Principal Display Panel (Cortizone 10 Intensive Healing For Eczema 01)

* Please review the disclaimer below.