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 November 1, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hydrocortisone USP 1%

  • Purpose

    Antipruritic (Anti-itch)

  • Uses

    For the 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 for external genital, feminine, and anal itching

  • Warnings

    For external use only

    If pregnant or breast-feeding, ask a health professional before use

    Do not use

    • In the eyes
    • For diaper rash
    • For external genital or feminine itching if you have a vaginal discharge
    • More than the recommended daily dosage unless directed by a doctor
    • This product in the rectum by using fingers or any mechanical device or applicator

    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. Do not begin use of any other hydrocortisone product unless you have asked a doctor
    • In case of bleeding when used for anal itching

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

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children 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 or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching
  • Other Information

    • Store at room temperature
    • Avoid excessive heat
  • Inactive Ingredients

    Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

  • Principal Display Panel - 1 oz. Tube Label

    Safetec®

    1% Hydrocortisone Cream

    For Itching, Inflammation, and Rashes

    Net Wt. 1oz. (28.4g)

    Reorder No. 53111

    Manufactured for: Safetec of America, Inc.
    Buffalo, NY 14215 | 1-800-456-7077
    Made In India KD/503

    Principal Display Panel - 1 oz. Tube Label
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4402
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4402-128.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2019
    Labeler - Safetec of America, Inc. (874965262)
    Registrant - Safetec of America, Inc. (874965262)
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