Label: MEDI-FIRST- hydrocortisone acetate cream

  • NDC Code(s): 71927-018-01, 71927-018-03
  • Packager: Orazen Inc
  • 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 17, 2023

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  • Drug Facts

  • Active ingredient

    Hydrocortisone 1%

    Purpose

    Anti-itch

  • Uses

    • for the temporary relief of itching associated with minor skin irritation,inflammation and rashed due to eczema, insect bites, poison ivy, poison oak,poison sumac, soaps, detergents, cosmetics,jewelry, sebortheic 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 use

    • for treatment of diaper rash
    • in eyes
    • for feminine itching

    Stop use and ask a doctor if

    • condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
    • you begin use of any other hydrocortisone product
    • bleeding occurs

    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 12 years of age: for external anal itching, consult a doctor
    • 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

    (continued on side panel)

    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • Other information

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

    cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolatum, phenoxyethanol, water

  • Questions or comments?

    1-800-634-7680

  • Package Labeling:

    image of pouch label

    image of box label

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-018-03144 in 1 BOX02/17/2023
    1NDC:71927-018-010.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/17/2023
    Labeler - Orazen Inc (080916640)
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