Label: HYDROCORTISONE cream

  • Category: HUMAN OTC DRUG LABEL

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 February 16, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                            Purpose

    Hydrocortisone 1%.................................... Anti-itch cream


  • PURPOSE


    Uses
    temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

    - eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
    - jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact
    a Poison Control Center immediately.
  • INDICATIONS & USAGE

    Uses
    temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

    - eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
    - jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor

    Other information

    - store at room temperature. Protect from freezing and excessive heat.
    - see carton or tube crimp for lot number and expiration date.
  • WARNINGS

    Warnings

    For external use only.

    Do not use:
    - in the eyes - for the treatment of diaper rash

    Ask a doctor before use if you are using any other hydrocortisone product

    Stop use and ask a doctor if

    - condition worsens, or if symptoms persist for more than 7 days

    - symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
  • DOSAGE & ADMINISTRATION


    Directions 


    - adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily
    - children under 2 years:do not use, ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    aloe barbadensis leaf juice, avena sativa kernal flour oat, beeswax, cetyl alcohol, citric acid,
    glyceryl stearate, isopropyl myristate, methylparaben, PEG-40 stearate, polysorbate 60,
    propylene glycol, propylparaben, purified water, sodium citrate, sodium stearate, sorbic acid,
    stearyl alcohol, tocopheryl acetate
  • PRINCIPAL DISPLAY PANEL

    c


  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-322
    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)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    OATMEAL (UNII: 8PI54V663Y)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-322-201 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/19/2009
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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