Label: 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

  • NDC Code(s): 41167-0035-0, 41167-0035-2, 41167-0035-3, 41167-0036-0, view more
    41167-0036-1, 41167-0039-0, 41167-0039-1, 41167-0039-6, 41167-0039-9, 41167-0105-6, 41167-0105-7, 41167-0105-8, 41167-0339-3, 41167-0339-6
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 1, 2007

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • 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

    Cooling
    gel formula

    itch relief

    Cools
    Itch
    Fast
    relief

    that

    lasts

    • Sunburn
    • Poison Ivy
    • Insect Bites

    Inflammation and redness

    Cools itch on Contact

     MAXIMUM STRENGTH

    Cortizone-10®

    COOLING RELIEF GEL

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

    Principal Display Panel
Cooling
gel formula
itch relief
Cools 
Itch 
Fast
relief
that
lasts
•	Sunburn
•	Poison Ivy
•	Insect Bites
Inflammation and redness
Cools itch on Contact
 MAXIMUM STRENGTH
Cortizone-10®
COOLING RELIEF GEL
Net wt 1oz (28g)  1% Hydrocortisone Anti-Itch Gel

  • Principal Display Panel

    10 Nourishing
    Ingredients

    Itch relief

    Fast

    Itch

    Lasts

    10

    Hours

    • Eczema
    • Sunburn
    • Dry, Itchy Skin

    Inflammation & redness

    Hydrates irritated, itchy skin

    PLUS ULTRA MOISTURIZING

    MAXIMUM STRENGTH

    Cortizone-10®

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

    Principal Display Panel
10 Nourishing
Ingredients
Itch relief
Fast
Itch
Lasts
10
Hours
•	Eczema
•	Sunburn
•	Dry, Itchy Skin
Inflammation & redness
Hydrates irritated, itchy skin
PLUS ULTRA MOISTURIZING
MAXIMUM STRENGTH
Cortizone-10®
Net wt 1oz (28g)  1% Hydrocortisone Anti-Itch CREME

  • Principal Display Panel

    Fast
    Itch

    Relief

    Lasts

    10

    Hours

    24 HOURS
    MOISTURIZING

    Itch Relief

    • Eczema
    • Psoriasis
    • Itchy Skin

    Inflammation & redness

    Extra creamy formula, gentle on skin

    INTENSIVE HEALING FORMULA

    MAXIMUM STRENGTH

    Cortizone-10®

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

    Principal Display Panel
Fast
Itch
Relief
Lasts
10 
Hours
24 HOURS
MOISTURIZING
Itch Relief
•	Eczema
•	Psoriasis
•	Itchy Skin
Inflammation & redness
Extra creamy formula, gentle on skin
INTENSIVE HEALING FORMULA†
MAXIMUM STRENGTH
Cortizone-10®
Net wt 1oz (28g)  1% Hydrocortisone Anti-Itch Crème

  • 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

    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

      

  • Principal Display Panel

    Fast

    Itch

    Relief

    Last

    10

    Hours

    Calming
    Aloe Vera

    Itch Relief

    • Psoriasis
    • Poison Ivy
    • Insect Bites

    Inflammation & redness

    Soothes itch, irritation & rashes

    DOCTORS

    #1 ITCH MEDICINE*TM 

    RECOMMEND

    MAXIMUM STRENGTH

    Cortizone-10® plus

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

    Principal Display Panel
Fast
Itch
Relief
Last
10
Hours
Calming
Aloe Vera
Itch Relief
•	Psoriasis
•	Poison Ivy
•	Insect Bites
Inflammation & redness
Soothes itch, irritation & rashes
DOCTORS
#1 ITCH MEDICINE*TM 
RECOMMEND 
MAXIMUM STRENGTH
Cortizone-10® plus 
Net wt 1oz (28g)  1% Hydrocortisone Anti-Itch CREME

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 COOLING RELIEF 
    hydrocortisone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0036-01 in 1 CARTON10/01/2008
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0036-11 in 1 CARTON10/01/2008
    235 g in 1 TUBE; Type 0: Not a Combination Product
    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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0039-11 in 1 CARTON09/01/2007
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0039-61 in 1 CARTON09/01/2007
    256 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-0039-01 in 1 CARTON09/01/2007
    314 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:41167-0039-91 in 1 CARTON09/01/2007
    435 g in 1 TUBE; Type 0: Not a Combination Product
    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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0035-01 in 1 CARTON12/01/2007
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0035-31 in 1 CARTON12/01/2007
    256 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-0035-21 in 1 CARTON12/01/2007
    335 g in 1 TUBE; Type 0: Not a Combination Product
    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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0339-31 in 1 CARTON09/01/2007
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0339-61 in 1 CARTON09/01/2007
    256 g in 1 TUBE; Type 0: Not a Combination Product
    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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0105-61 in 1 CARTON09/01/2007
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0105-81 in 1 CARTON09/01/2007
    235 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-0105-71 in 1 CARTON09/01/2007
    356 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/01/2007
    Labeler - Chattem, Inc. (003336013)