Label: MEDI-FIRST HYDROCORTISONE 1%- hydrocortisone acetate cream
MEDI-FIRST 1% HYDROCORTISONE- hydrocortisone acetate cream

  • NDC Code(s): 47682-207-12, 47682-207-35, 47682-207-73, 47682-207-99, view more
    47682-923-73
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Hydrocortisone acetate (equivalent to Hydrocorisone 1%)

  • PURPOSE

    Purpose

    Anti-itch cream

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of itching associated with minor skin irritations and rashes
    • other uses of this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use for the treatment of diaper rash. Consult a doctor.

  • WHEN USING

    When using this product

    • avoid contact with eyes
    • do not begin use of any other hydrocortisone product unless you've consulted a doctor
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days
  • 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 and older: apply to the affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use, consult a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • clean the affected area
    • store at room temperature (do not freeze)
    • tamper evident. Do not use any opened or torn packets
    • you may reportr a serioud adverse reaction to this product to 800-634-7680
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medi-First®

    1% Hydrocortisone Cream

    Temporary relief of itching associated with minor skin irritation and rashes

    Item #21173

    0.9 g (1/32 oz)

    Packets - 25 per box

    21173

  • PRINCIPAL DISPLAY PANEL

    Medi-First® Plus

    Hydrocortisone Cream 1%

    Temporary relief of itching associated with minor skin irritations and rashes

    25 Units/Net Wt 0.9 g (1/32 oz)

    93373

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST HYDROCORTISONE 1% 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-207
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-207-1210 in 1 BOX06/01/202104/30/2028
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-207-35144 in 1 BOX06/01/202104/30/2028
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-207-7325 in 1 BOX06/01/202104/30/2028
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-207-990.9 g in 1 PACKET; Type 0: Not a Combination Product06/01/202104/30/2028
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/202104/30/2028
    MEDI-FIRST 1% HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-923
    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
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-923-7325 in 1 BOX06/01/202104/30/2028
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/202104/30/2028
    Labeler - Unifirst First Aid Corporation (832947092)
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