Label: HYDROCORTISONE cream

  • NDC Code(s): 61010-5800-1, 61010-5800-2, 61010-5800-3, 61010-5800-4
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone 1.0%

  • Purpose

    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 scrapes
    • other uses of this product should be only under the advice and supervision of a doctor
  • Warnings:

    • For external use only

    • Do not usefor the treatment of diaper rash
    • in eyes
    • for feminine itching
    • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
    • with any other Hydrocortisone product unless you have consulted a doctor

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
    • children under 2 years of age: do not use, consult a doctor
    • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • children under 12 years of age: for external anal itching, consult a doctor
  • Other information:

    • store at room temperature (do not freeze)
    • do not use any opened or torn packets
  • Inactive ingredients:

    emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

  • Questions or Comments? 1-800-456-7077

    Manufactured by
    SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215 . 800-456-7077
    www.safetec.com

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

    Safetec

    1% Hydrocortisone Cream™

    0.9 g (1/32 oz.)

    Safetec of America, Inc.

    Buffalo, NY 14215

    800-456-7077

    PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label
  • PRINCIPAL DISPLAY PANEL – Box Label

    NDC 61010-5800-2

    Safetec

    First Aid

    1% Hydrocortisone Cream

    For Temporary Relief of

    Itching Associated with

    Minor Skin Irritations,

    Inflammation, or Rashes

    Reorder no. 53110

    To reorder:

    Call: 1-800-456-7077

    Fax: 716-895-2969

    Online: www.safetec.com

    PRINCIPAL DISPLAY PANEL – Box Label
  • PRINCIPAL DISPLAY PANEL – 10 Packet Box Label

    Safetec®

    FIRST AID

    Hydrocortisone Cream

    1% Hydrocortisone for relief from itching,
    inflammation, and rashes

    10 Packets

    Each Packet Net Wt. 0.9g

    Made in USA

    Reorder no. 53108

    PRINCIPAL DISPLAY PANEL – 10 Packet Box Label
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5800
    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
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5800-325 in 1 BOX12/15/2010
    1NDC:61010-5800-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:61010-5800-2144 in 1 BOX12/15/2010
    2NDC:61010-5800-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:61010-5800-410 in 1 BOX04/01/2020
    3NDC:61010-5800-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/15/2010
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-5800)
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