Label: CRANE SAFETY HYDROCORTISONE- hydrocortisone cream

  • NDC Code(s): 73408-633-73, 73408-933-73
  • Packager: Crane Safety LLC
  • 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 March 31, 2023

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  • Drug Facts

  • Active ingredient (in each gram)

    Hydrocortisone 1.0%

  • Purpose

    Antipruritic (Anti-itch)

  • Uses

    • for the temporary relief of itching associated with minor skin irritation, inflammation and rashes
    • for externalgenital,femine and anal itching
    • other uses for this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only

  • Do not use

    • for the teatment of diaper rash
    • with any other hydrocortisone product unless you have consulted a doctor
    • if you have vaginal discharge, consult 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 over:

    apply to affected area not more than 3 to 4 times daily

    Children under 2 years:

    do not use and ask a doctor

    For external 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 59º to 86ºF (15º to 30ºC)
    • tamper evident, do not use if packet is toen, cut or opened
    • avoid excessive heat and humidity
  • Inactive ingredients

    benzoic acid*, chlorphenesin*, citric acid*, emulsifying wax*, ethyl alcohol*, glycerin*, glycerol monostearate*, methylparaben, mineral oil, paraffin*, petrolatum, phenoxyethanol*, polysorbate 80*, propylparaben*, purified water, titanium dioxide*, trisodium citrate*, white wax*

    May contain*

  • Questions or comments?

    877.506.4291

  • Crane Safety Hydrocortisone 1% Cream Label

    Hydrocortisone Cream 1%

    Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

    Product CS93373

    0.9 g (1/32 oz) Packets

    25/Box

    CRANE Safety®

    Crane

  • Crane Safety Hydrocortisone Label

    Hydrocortisone Cream 1%

    Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

    Product CS93373

    0.9 g (1/32 oz) Packets

    25/Box

    CRANE Safety®

    Crane S

  • INGREDIENTS AND APPEARANCE
    CRANE SAFETY HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-933
    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
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-933-7325 in 1 BOX01/17/2020
    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 finalpart34801/17/2020
    CRANE SAFETY HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-633
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-633-7325 in 1 BOX01/17/202012/01/2024
    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 finalpart34801/17/202012/01/2024
    Labeler - Crane Safety LLC (080998015)
    Registrant - Unifirst First Aid Corporation (832947092)
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