Cortizone 10 Cooling Relief

Dosage form: gel
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Chattem, Inc.
NDC Code: 41167-0036

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cortizone-10

Cortizone-10® Cooling Relief Gel

Active Ingredient: 

Hydrocortisone 1%

Purpose

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

Warnings

For external use only

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.

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. 

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, 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® Creme 

Active Ingredient:

Hydrocortisone 1%

Purpose

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

Warnings

For external use only

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.

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. 

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® Creme Intensive Healing Formula  

Active Ingredient:

Hydrocortisone 1%

Purpose

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

Warnings

For external use only

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.

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. 

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

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

Cortizone-10® Ointment  

Active Ingredient:

Hydrocortisone 1%

Purpose

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

Warnings

For external use only

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.

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. 

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

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

Cortizone-10® Plus Creme 

Active Ingredient:

Hydrocortisone 1%

Purpose

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

Warnings

For external use only

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.

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. 

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, 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

Principal Display Panel

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

Principal Display Panel

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

Principal Display Panel

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

  

Principal Display Panel

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

CORTIZONE 10 COOLING RELIEF 
hydrocortisone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0036
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
DIMETHICONE 
EDETATE DISODIUM 
GLYCERIN 
MALTODEXTRIN 
METHYLPARABEN 
POLYSORBATE 60 
PROPYLPARABEN 
SODIUM CITRATE 
WATER 
CYCLOMETHICONE 5 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:41167-0036-01 TUBE (1 TUBE) in 1 CARTON
128 g in 1 TUBE
2NDC:41167-0036-11 TUBE (1 TUBE) in 1 CARTON
235 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/01/2008
CORTIZONE 10 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0039
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM SULFATE 
YELLOW WAX 
CALCIUM ACETATE 
CETOSTEARYL ALCOHOL 
GLYCERIN 
MALTODEXTRIN 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
PROPYLPARABEN 
SODIUM CETOSTEARYL SULFATE 
SODIUM LAURYL SULFATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:41167-0039-11 TUBE (1 TUBE) in 1 CARTON
128 g in 1 TUBE
2NDC:41167-0039-61 TUBE (1 TUBE) in 1 CARTON
256 g in 1 TUBE
3NDC:41167-0039-01 TUBE (1 TUBE) in 1 CARTON
314 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34809/01/2007
CORTIZONE 10 INTENSIVE HEALING 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
DIMETHICONE 
PETROLATUM 
CETYL ALCOHOL 
ALOE VERA LEAF 
STEARYL ALCOHOL 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
VITAMIN A PALMITATE 
GLYCERYL MONOSTEARATE 
EDETIC ACID 
POTASSIUM HYDROXIDE 
DIAZOLIDINYL UREA 
BENZYL ALCOHOL 
METHYLPARABEN 
BUTYLATED HYDROXYTOLUENE 
PROPYLPARABEN 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:41167-0035-01 TUBE (1 TUBE) in 1 CARTON
128 g in 1 TUBE
2NDC:41167-0035-31 TUBE (1 TUBE) in 1 CARTON
256 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2007
CORTIZONE 10 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0339
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:41167-0339-31 TUBE (1 TUBE) in 1 CARTON
128 g in 1 TUBE
2NDC:41167-0339-61 TUBE (1 TUBE) in 1 CARTON
256 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34809/01/2007
CORTIZONE 10 PLUS 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM SULFATE 
YELLOW WAX 
CALCIUM ACETATE 
CETOSTEARYL ALCOHOL 
CHOLECALCIFEROL 
GLYCERIN 
ISOPROPYL PALMITATE 
MALTODEXTRIN 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
PROPYLENE GLYCOL 
PROPYLPARABEN 
VITAMIN A PALMITATE 
SODIUM CETOSTEARYL SULFATE 
SODIUM LAURYL SULFATE 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
CORN OIL 
Packaging
#Item CodePackage Description
1NDC:41167-0105-61 TUBE (1 TUBE) in 1 CARTON
128 g in 1 TUBE
2NDC:41167-0105-81 TUBE (1 TUBE) in 1 CARTON
235 g in 1 TUBE
3NDC:41167-0105-71 TUBE (1 TUBE) in 1 CARTON
356 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34809/01/2007
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 2830410721MANUFACTURE(41167-0036, 41167-0039, 41167-0035, 41167-0339, 41167-0105), RECOVERY(41167-0036, 41167-0039, 41167-0035, 41167-0339, 41167-0105), RELABEL(41167-0036, 41167-0039, 41167-0035, 41167-0339, 41167-0105), REPACK(41167-0036, 41167-0039, 41167-0035, 41167-0339, 41167-0105)

Revised: 03/2014
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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