Label: HYDROCORTISONE CREAM 1% 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 February 13, 2021

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

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Antipruritic (Anti-itch)

  • Uses

    Relieves itches and rashes due to:

    • Eczema
    • Psoriasis
    • Seborrheic dermatitis
    • Poison ivy
    • Poison oak
    • Poison sumac
    • Insect bites
    • External anal itching
    • Soaps
    • Detergents
    • Cosmetics
    • Jewelry

    Temporary relief of external anal and genital itching.

    Other use of the product should only be under the advice and supervision of a doctor.

  • Warnings

    For external use only

    Do not use:

    • In the eyes
    • For diaper rash
    • If you have vaginal discharge
    • More than the recommended dosage

    Ask doctor before use:

    • If you are pregnant or breast feeding

    Stop use and ask a doctor if:

    • Condition worsens, or is 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.

    ​When using this product:

    • Do not put this product into rectum by using fingers or any mechanical device or applicator.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

  • Directions

    • Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
    • Children under 2 years of age - Do not use. Consult a doctor.
      • For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.
  • Other Information

    • store between 20ºC and 25ºC (68ºFk and 77ºF)
    • avoid excessive heat and humidity
  • Inactive Ingredients

    Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

  • PRINCIPAL DISPLAY PANEL

    Questions of comments? Call 1-866-747-7365

    Manufactured for : SOLA Pharmaceuticals

    Baton Rouge, LA 70810


    Store in a dry, cool place

    Hydrocortisone 1% Cream

    NDC 70512-101-30


    Qty: 28.4g

    Hydrocortisone boxHydrocortisone Tube

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE CREAM 1% 
    hydrocortisone cream 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-101
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETETH-20 (UNII: I835H2IHHX)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-101-301 in 1 CARTON04/16/2020
    130 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 finalpart34804/16/2020
    Labeler - SOLA Pharmaceuticals (080121345)