CORTIZONE 10 COOLING RELIEF- hydrocortisone gel CORTIZONE 10- hydrocortisone cream CORTIZONE 10 INTENSIVE HEALING- hydrocortisone cream CORTIZONE 10- hydrocortisone ointment CORTIZONE 10 PLUS- hydrocortisone cream
Cortizone 10 Plus by
Drug Labeling and Warnings
Cortizone 10 Plus by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- Cortizone-10® Cooling Relief Gel
- Active Ingredient:
- Purpose
-
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:
-
Warnings
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
- in the genital area if you have a vaginal discharge. Consult a doctor.
-
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:
- Other information
-
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:
- Purpose
-
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:
-
Warnings
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
- in the genital area if you have a vaginal discharge. Consult a doctor.
-
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:
- Other information
-
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:
- Purpose
-
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:
-
Warnings
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
- in the genital area if you have a vaginal discharge. Consult a doctor.
-
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:
- Other information
-
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:
- Purpose
-
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:
-
Warnings
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
- in the genital area if you have a vaginal discharge. Consult a doctor.
-
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:
- Other information
- Inactive Ingredients
- Cortizone-10® Plus Creme
- Active Ingredient:
- Purpose
-
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:
-
Warnings
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
- in the genital area if you have a vaginal discharge. Consult a doctor.
-
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:
- Other information
-
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
- Principal Display Panel
- Principal Display Panel
-
Principal Display Panel
Fast
Itch
Relief
Last
10
Hours
Water
Resistant Formula
Itch Relief
-
Psoriasis
-
Poison Ivy
- Irritation & Rashes
Inflammation & redness
Locks in moisture
Anti – Itch Ointment
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
-
Psoriasis
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
CORTIZONE 10 COOLING RELIEF
hydrocortisone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 41167-0036 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 41167-0036-0 1 in 1 CARTON 10/01/2008 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 41167-0036-1 1 in 1 CARTON 10/01/2008 2 35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/01/2008 CORTIZONE 10
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 41167-0039 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM SULFATE (UNII: 34S289N54E) YELLOW WAX (UNII: 2ZA36H0S2V) CALCIUM ACETATE (UNII: Y882YXF34X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 41167-0039-9 1 in 1 CARTON 09/01/2007 1 35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 41167-0039-1 1 in 1 CARTON 09/01/2007 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC: 41167-0039-6 1 in 1 CARTON 09/01/2007 3 56 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC: 41167-0039-0 1 in 1 CARTON 09/01/2007 4 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 09/01/2007 CORTIZONE 10 INTENSIVE HEALING
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 41167-0035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) PETROLATUM (UNII: 4T6H12BN9U) CETYL ALCOHOL (UNII: 936JST6JCN) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EDETIC ACID (UNII: 9G34HU7RV0) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) BENZYL ALCOHOL (UNII: LKG8494WBH) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 41167-0035-2 1 in 1 CARTON 12/01/2007 1 35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 41167-0035-0 1 in 1 CARTON 12/01/2007 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC: 41167-0035-3 1 in 1 CARTON 12/01/2007 3 56 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 12/01/2007 CORTIZONE 10
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 41167-0339 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 41167-0339-3 1 in 1 CARTON 09/01/2007 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 41167-0339-6 1 in 1 CARTON 09/01/2007 2 56 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 09/01/2007 CORTIZONE 10 PLUS
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 41167-0105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM SULFATE (UNII: 34S289N54E) YELLOW WAX (UNII: 2ZA36H0S2V) CALCIUM ACETATE (UNII: Y882YXF34X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHOLECALCIFEROL (UNII: 1C6V77QF41) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 41167-0105-6 1 in 1 CARTON 09/01/2007 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 41167-0105-8 1 in 1 CARTON 09/01/2007 2 35 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC: 41167-0105-7 1 in 1 CARTON 09/01/2007 3 56 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 09/01/2007 Labeler - Chattem, Inc. (003336013)
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