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
- eczema
- 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
- eczema
- 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
- eczema
- 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
- eczema
- 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
- eczema
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
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- 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
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- 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
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- 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
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- 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
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- 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
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- 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
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- 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
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- 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
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- 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
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
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
- Skin Irritation & Rashes
- Inflammation & Redness
- Sunburn Itch
- Insect Bites, Poison Ivy
- Eczema & Psoriasis
- Dry, Itchy Skin
- Eczema & Psoriasis
- Inflammation, Irritation & Redness
- Calms, Nourishes, Hydrates
- Safe for Sensitive Skin
- Skin Irritation & Rashes
- Inflammation & Redness
- Insect Bites, Poison Ivy
- Eczema & Psoriasis
- Dry, Itchy Skin
- Skin Irritation & Rashes
- Inflammation & Redness
- Insect Bites, Poison Ivy
- 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:
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
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:
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:
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.