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

Purpose

Anti-itch

Description

Hydrocortisone 1%


Medication Information

Warnings

For external use only

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

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
Other Information
  • contents filled by weight, not volume
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  

Description

Hydrocortisone 1%

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

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%

Active Ingredient:

Hydrocortisone 1%

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

Warnings

For external use only

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

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

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%

Active Ingredient:

Hydrocortisone 1%

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)