Label: HYDROCORTISONE cream

  • 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 June 23, 2017

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

  • ACTIVE INGREDIENT

    Active ingredient                                  Purpose

    Hydrocortisone 1%                              Antipruritic (anti-itch)

  • Warnings

    ​For external use only

  • Purpose

    Uses: For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to, eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and external genital, feminine, and anal itching.

  • DO NOT USE

    Do Not Use:

    • in the eyes
    • longer than 1 week unless directed by a physician
    • for diaper rash
    • if you have vaginal discharge
    • more than recommended daily dosage unless directed by a doctor
    • in the rectum using fingers or any other mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product.
    • in case of bleeding when used for anal itching
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of Reach of Children

    • if swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 2 years of age and older:

    • apply evenly to affected area no more than 3 or 4 times dailyChildren under 2 years of age consult a doctor
    • when used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting and blotting with bathroom tissue or soft cloth before applying. Children under 12: consult doctor before using for anal itching.

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Cetostearyl alcohol, glyceryl monostearate, methylchloroisothiazolinone, propylene glycol, purified water, stearic acid, trolamine, white soft paraffin 

  • SPL UNCLASSIFIED SECTION

    Other information:

    • store at room temperature
    • avoid excessive heat
  • INDICATIONS & USAGE

    For temporary relief of minor skin irritations and external itching.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Dynarex Hydrocortisone Items 1137 and 1139

    Hydro 1139.jpg

    Hydrocortisone 1137 - 1139

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-417-0128.4 g in 1 TUBE; Type 0: Not a Combination Product10/07/2016
    2NDC:67777-417-020.9 g in 1 PACKET; Type 0: Not a Combination Product10/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/07/2016
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co.,Ltd858030888manufacture(67777-417)