FDA Label for Cortizone 10

View Indications, Usage & Precautions

Cortizone 10 Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient:



Hydrocortisone 1%

Hydrocortisone 1%

Hydrocortisone 1%

Hydrocortisone 1%

Hydrocortisone 1%


Purpose



Anti-itch

Anti-itch

Anti-itch

Anti-itch

Anti-itch


Uses



  • 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
    • temporarily relieves external anal and genital itching
    • other uses of this product should only be under the advice and supervision of a doctor
      • 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
        • temporarily relieves external anal and genital itching
        • other uses of this product should only be under the advice and supervision of a doctor
          • 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
            • temporarily relieves external anal and genital itching
            • other uses of this product should only be under the advice and supervision of a doctor
              • 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
                • temporarily relieves external anal and genital itching
                • other uses of this product should only be under the advice and supervision of a doctor
                  • 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
                    • temporarily relieves external anal and genital itching
                    • other uses of this product should only be under the advice and supervision of a doctor

Do Not Use



  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
    • in the genital area if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult a doctor.
      • in the genital area if you have a vaginal discharge. Consult a doctor.
      • for the treatment of diaper rash. Consult a doctor.
        • in the genital area if you have a vaginal discharge. Consult a doctor.
        • for the treatment of diaper rash. Consult a doctor.
          • in the genital area if you have a vaginal discharge. Consult a doctor.
          • 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
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
    • avoid contact with eyes
    • do not use more than directed unless told to do so by a doctor.
    • do not put directly into the rectum by using fingers or any mechanical device or applicator
      • avoid contact with eyes
      • do not use more than directed unless told to do so by a doctor.
      • do not put directly into the rectum by using fingers or any mechanical device or applicator
        • avoid contact with eyes
        • do not use more than directed unless told to do so by a doctor
        • do not put directly into the rectum by using fingers or any mechanical device or applicator
          • avoid contact with eyes
          • do not use more than directed unless told to do so by a doctor.
          • do not put directly into the rectum by using fingers or any mechanical device or applicator

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
  • rectal bleeding occurs
    • 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
    • rectal bleeding occurs
      • 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
      • rectal bleeding occurs
        • 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
        • rectal bleeding occurs
          • 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
          • rectal bleeding occurs

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. 

If swallowed, get medical help or contact a Poison Control Center right away. 

If swallowed, get medical help or contact a Poison Control Center right away. 

If swallowed, get medical help or contact a Poison Control Center right away. 

If swallowed, get medical help or contact a Poison Control Center right away. 


Directions



  • for itching of skin irritation, inflammation, and rashes:
    • 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
      • for external anal and genital itching, adults:
        • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
        • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
        • apply to affected area not more than 3 to 4 times daily
        • children under 12 years of age: ask a doctor
          • for itching of skin irritation, inflammation, and rashes:
            • 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
              • for external anal and genital itching, adults:
                • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
                • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
                • apply to affected area not more than 3 to 4 times daily
                • children under 12 years of age: ask a doctor
                  • for itching of skin irritation, inflammation, and rashes:
                    • 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
                      • for external anal and genital itching, adults:
                        • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
                        • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
                        • apply to affected area not more than 3 to 4 times daily
                        • children under 12 years of age: ask a doctor
                          • for itching of skin irritation, inflammation, and rashes:
                            • 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
                              • for external anal and genital itching, adults:
                                • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
                                • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
                                • apply to affected area not more than 3 to 4 times daily
                                • children under 12 years of age: ask a doctor
                                  • for itching of skin irritation, inflammation, and rashes:
                                    • 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
                                      • for external anal and genital itching, adults:
                                        • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
                                        • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
                                        • apply to affected area not more than 3 to 4 times daily
                                        • children under 12 years of age: ask a doctor

Other Information



  • contents filled by weight, not volume
    • contents filled by weight, not volume
      • contents filled by weight, not volume
        • contents filled by weight, not volume
          • contents filled by weight, not volume

Inactive Ingredients



aloe barbadensis leaf juice, avena sativa (oat) kernel extract, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, propylparaben, SD Alcohol 40-2 (15%), sodium citrate, water

CHATTEM®

*Refers to the ingredient hydrocortisone

Distributed by CHATTEM, INC.

P.O. Box 2219, Chattanooga,

TN 37409-0219 USA ©2008

www.ditchtheitch.com 0042740-02

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

*Refers to the ingredient hydrocortisone

CHATTEM®

Distributed by CHATTEM, INC.

P.O. Box 2219, Chattanooga,TN 37409-0219 USA ©2008

www.chattem.com 0040433-02

Minor change

water, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-21, steareth-2, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, hydrolyzed collagen, hydrolyzed elastin, retinyl palmitate, hydrolyzed jojoba esters, glyceryl stearate, EDTA, PPG-12/SMDI copolymer, potassium hydroxide, avena sativa (oat) kernel extract, menthyl lactate, diazolidinyl urea, benzyl alcohol, methylparaben, BHT, propylparaben

*Refers to the ingredient hydrocortisone

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

CHATTEM®

Distributed by CHATTEM, INC.

P.O. Box 2219, Chattanooga,

TN 37409-0219 USA ©2008  0040439-02

petrolatum

*Refers to the ingredient hydrocortisone

CHATTEM®

Distributed by CHATTEM, INC.

P.O. Box 2219, Chattanooga, TN 37409-0219 USA ©2008  

www.chattem.com 

0040437-02

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopheryl acetate, water, zea mays (corn) oil

*Refers to the ingredient hydrocortisone

CHATTEM®

Distributed by CHATTEM, INC.

P.O. Box 2219, Chattanooga,TN 37409-0219 USA ©2008

www.chattem.com 0040435-02


Principal Display Panel



NEW

Cools Itch Fast

Fast Acting

Long Lasting!

  • Insect Bites
  • Poison Ivy
  • Sunburn Itch
  • Inflammation, Irritation & Redness
  • Eczema & Psoriasis
  • Cools on Contact

    DOCTORS

    #1 ITCH MEDICINE*TM 

    RECOMMEND

    Cools the Itch & Continues Relieving for Hours

    MAXIMUM STRENGTH

    Cortizone-10®

    COOLING RELIEF GEL

    Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch Gel

    Relieves Itch Fast

    SERIOUS MEDICINE,

    FAST COMFORT: 

    • Skin Irritation & Rashes
    • Inflammation & Redness
    • Sunburn Itch
    • Insect Bites, Poison Ivy
    • Eczema & Psoriasis
    • with Healing Aloe

      DOCTORS

      #1 ITCH MEDICINE*TM 

      RECOMMEND

      THE ITCH MEDICINE DOCTORS RECOMMEND*

      MAXIMUM STRENGTH

      Cortizone-10®

      Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch CREME

      Helps Heal Itch Fast

      CLINICALLY PROVEN TO MOISTURIZE

      24 HOURS

      • Dry, Itchy Skin
      • Eczema & Psoriasis
      • Inflammation, Irritation & Redness
      • Calms, Nourishes, Hydrates
      • Safe for Sensitive Skin
      • with Antioxidants & Chamomile

        DOCTORS

        #1 ITCH MEDICINE*TM 

        RECOMMEND

        Ultra Creamy Formula Helps Heal Problem Skin

        MAXIMUM STRENGTH

        Cortizone-10®

        INTENSIVE HEALING FORMULA

        Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch Creme

        Relieves Itch Fast

        SERIOUS MEDICINE,

        FAST COMFORT: 

        • Skin Irritation & Rashes
        • Inflammation & Redness
        • Insect Bites, Poison Ivy
        • Eczema & Psoriasis
        • Water Resistant Formula

          Helps Seal in Healing

          DOCTORS

          #1 ITCH MEDICINE*TM 

          RECOMMEND

          THE ITCH MEDICINE DOCTORS RECOMMEND*

          MAXIMUM STRENGTH

          Cortizone-10®

          Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch OINTMENT

            

          Relieves Itch Fast

          SERIOUS MEDICINE,

          FAST COMFORT: 

          • Dry, Itchy Skin
          • Skin Irritation & Rashes
          • Inflammation & Redness
          • Insect Bites, Poison Ivy
          • Eczema & Psoriasis
          • Enriched with Aloe plus Vitamins A & E

            DOCTORS

            #1 ITCH MEDICINE*TM 

            RECOMMEND

            THE ITCH MEDICINE DOCTORS RECOMMEND*

            MAXIMUM STRENGTH

            Cortizone-10® plus

            HEALING MOISTURIZERS

            Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch CREME


* Please review the disclaimer below.