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

  • NDC Code(s): 47682-611-12, 47682-611-35, 47682-611-73, 47682-611-99, view more
    47682-633-73
  • Packager: Unifirst First Aid Corporation
  • 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 August 10, 2023

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  • Drug Facts

  • Active ingredient

    Hydrocortisone 1.0%

  • Purpose

    Antipruritic (ant-itch)

  • Uses

    • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
    • for external genital, feminine, and anal itching
    • 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 the treatment of diaper rash
    • with any other Hydrocortisone product unless you have consulted a doctor
    • if you have a vaginal discharge, consult a doctor

    When using this product

    • avoid contact with eyes
    • do not put this product into rectum by using fingers, mechanical device or applicator
    • do not exceed recommended daily dosage unless directed by a doctor

    Stop use and ask a doctor if

    • condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
    • rectal bleeding occurs
  • 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: do not use and ask a doctor

    For external anal and genital itching in adults:

    • when practical, clean affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying

    Children under 12 years of age: ask a doctor

  • Other information

    • store at room temperature 59° to 86° F (15° to 30° C)
    • tamper evident, do not use if packet is torn, cut or opened
    • avoid excessive heat and humidity
  • Inactive ingredients

    benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate

  • Questions or comments?

    1-800-634-7680

  • Medi-First 1% Hydrocortisone Cream Label

    Medi-First®

    1% Hydrocortisone Cream

    Temporary relief of itching associated with minor skin irritation and rashes

    Item # 21173

    0.9g (1/32oz) Packets

    25 per box

    Medi-First Hydro

  • Medi-First Plus 1% Hydrocortisone Cream Label

    Medi-First® Plus

    Hydrocortisone Cream 1%

    Temporary relief of itching associated with minor skin irritation and rashes

    25 Units of 0.9g (1/32oz) Packets

    Item # 93373

    Medi-First Plus

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST PLUS HYDROCORTISONE 
    1 % hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-633
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-633-7325 in 1 BOX01/01/202012/01/2024
    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 not finalpart34801/01/202012/01/2024
    MEDI-FIRST HYDROCORTISONE 
    1 % hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-611
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-611-35144 in 1 BAG01/01/202012/01/2024
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-611-7325 in 1 BOX01/01/202012/01/2024
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-611-1210 in 1 BOX01/01/202012/01/2024
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-611-990.9 g in 1 PACKET; Type 0: Not a Combination Product01/01/202012/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/202012/01/2024
    Labeler - Unifirst First Aid Corporation (832947092)
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