Label: CORTIZONE 10 POISON IVY RELIEF PADS- hydrocortisone gel 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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

  • SPL UNCLASSIFIED SECTION

    Cortizone-10® Poison Ivy Relief Pads

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  • Active Ingredient:

    Hydrocortisone 1%

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  • Purpose

    Anti-itch

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  • Uses

    • temporarily relieves itching and discomfort associated with minor skin irritations, inflammation and rashes due to poison ivy, poison oak and poison sumac.
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  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes
    • do not use more than directed unless told to do so by a doctor. 

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. 

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  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
      • select one Snapplicator and snap to release product through pad top
      • gently dab on affected area, then rub product into skin until thoroughly absorbed

    • children under 2 years of age: ask a doctor
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  • Inactive Ingredients

    aloe barbadensis leaf juice, avena sativa (oat) kernel extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium, acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate-60, PPG-3 benzyl ether myristate,  propylparaban, SD alcohol 40 (15 %), sodium citrate, water (283-034)

    Dist, by: Chattem, Inc. P.O. Box 2219
    Chattanooga,TN 37409-0219 USA
    www.Cortizone10.com

    ©2012 Chattem, Inc.

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  • Principal Display Panel

    NEW!
    MAXIMUM STRENGTH
    Cortizone-10®
    1% Hydrocorisone Ani-Itch Gel
    Poison Ivy

    Relief Pads

    • Relives Itch Fast
    • Cools Skin on Contact
    • Soothes Inflammation
    • Strongest Itch Medicine Without a Prescription

    with Healing Aloe
    10 Self-contained Snapplicators
    Total Net wt 0.81 oz (23 g)/ 0.08 oz (2.3 g) each

    NEW!
MAXIMUM STRENGTH
Cortizone-10®
1% Hydrocorisone Ani-Itch Gel
Poison Ivy
Relief Pads
•	Relives Itch Fast
•	Cools Skin on Contact
•	Soothes Inflammation
•	Strongest Itch Medicine Without a Prescription
with Healing Aloe
10 Self-contained Snapplicators
Total Net wt 0.81 oz (23 g)/ 0.08 oz (2.3 g) each

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  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 POISON IVY RELIEF PADS 
    hydrocortisone gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-0332
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    OAT  
    ICODEXTRIN  
    DIMETHICONE  
    EDETATE DISODIUM  
    GLYCERIN  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)  
    ISOHEXADECANE  
    MALTODEXTRIN  
    MENTHYL LACTATE, (-)-  
    METHYL GLUCETH-20  
    METHYLPARABEN  
    POLYSORBATE 60  
    PPG-3 BENZYL ETHER MYRISTATE  
    SODIUM CITRATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0332-0 10 in 1 CARTON
    1 2.3 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 01/20/2013
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 2 830410721 MANUFACTURE(41167-0332)
    Establishment
    Name Address ID/FEI Business Operations
    Tapemark Company 006154595 PACK(41167-0332)
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