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 May 4, 2016

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

    For temporary relief of:

    • minor skin irritations

    Itches and rashes due to:

    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry

    and for external itching of:

    • 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 physician if:

    • the condition persists or gets worse
    • symptoms clear up and appear again within a few days
    • you are pregnant or breast feeding
  • 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:

    • apply evenly to affected area no more than 3 or 4 times daily.

    Children under 2 years of age:

    • Do not use
    • consult a physician

    Adults:

    • when practical, 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
    • apply externally to the area up to 6 times daily or after each bowel movement

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, sodium betabisulphate, white soft paraffin, water (purified)

  • SPL UNCLASSIFIED SECTION

    Other information:

    • store at 20 deg. to 25 deg. C (68 deg. - 77 deg. F)
    • avoid excessive heat and humidity
  • INDICATIONS & USAGE

    For temporary relief of minor skin irritations and external itching.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Dynarex Hydrocortisone Items 1137 and 1139

    Hydro1139.jpg

    Hydrocortisone 1137 - 1139

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-415
    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)  
    ceteth-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-415-0128.4 g in 1 TUBE; Type 0: Not a Combination Product12/02/2015
    2NDC:67777-415-020.9 g in 1 PACKET; Type 0: Not a Combination Product12/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/02/2015
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Pvt. Ltd.650970176manufacture(67777-415)