Cortizone-10

Cortizone-10
SPL v16
SPL
SPL Set ID bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c
Route
TOPICAL
Published
Effective Date 2025-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Dimethicone Edetate Disodium Glycerin Maltodextrin Methylparaben Polysorbate 60 Propylparaben Sodium Citrate Water Cyclomethicone 5 Alcohol Aluminum Sulfate Yellow Wax Calcium Acetate Cetostearyl Alcohol Mineral Oil Petrolatum Sodium Cetostearyl Sulfate Sodium Lauryl Sulfate Cetyl Alcohol Stearyl Alcohol Vitamin A Palmitate Glyceryl Monostearate Edetic Acid Potassium Hydroxide Diazolidinyl Urea Benzyl Alcohol Butylated Hydroxytoluene Alpha-tocopherol Acetate Cholecalciferol Isopropyl Palmitate Propylene Glycol Corn Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-09-01 Until 2025-08-25

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

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
Warnings

For external use only

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
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.
Inactive I

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

Cortizone-10 ® Crem e  

Active Ingredient

Hydrocortisone 1%

Other Information
  • contents filled by weight, not volume
Active Ingredient:

Hydrocortisone 1%

Inactive Ingredients

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

Cortizone-10 ® Cre me Intensive Healing Formula  

Principal Display Panel

Cooling

gel formula


itch relief


Cools

Itch

Fast

relief


that


lasts

  • Sunburn

  • Poison Ivy

  • Insect Bites

Inflammation and r edness

Cools itch on Contact

MAXIMUM STRENGTH

Cortizone-10®

C OOLING R ELIEF GEL

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

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
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
Keep Out of Reach of Children.

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


Structured Label Content

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
Purpose

Anti-itch

Warnings

For external use only

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
Do Not Use (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.
Inactive I

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

Cortizone-10 ® Crem e  

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)
  • contents filled by weight, not volume
Active Ingredient:

Hydrocortisone 1%

Inactive Ingredients

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

Cortizone-10 ® Cre me Intensive Healing Formula  

Principal Display Panel

Cooling

gel formula


itch relief


Cools

Itch

Fast

relief


that


lasts

  • Sunburn

  • Poison Ivy

  • Insect Bites

Inflammation and r edness

Cools itch on Contact

MAXIMUM STRENGTH

Cortizone-10®

C OOLING R ELIEF GEL

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

When Using This Product (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
Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)