Label: PROCURE- hydrocortisone acetate ointment

  • NDC Code(s): 55681-224-02, 55681-224-03
  • Packager: TWIN MED, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient (per gram)

    Hydrocortisone Acetate, USP (1% w/w)

  • Purpose

    Antipruritic (Anti-Itch)


  • Uses

    For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, 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

    • In the eyes
    • for diaper rash
    • if you have vaginal discharge
    • more than recommended dosage.

    Ask a doctor before use if

    you are pregnant or breast feeding

    Stop use and ask a doctor if

    • the condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children

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

  • Directions

    • Adults and children over 2 years of age
    • Apply evenly to affected area no more than 3 to 4 times daily
    • Children under 2 years of age
    • Do not use, consult a doctor
    • Adults- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • Gently dry, patting or blotting with bathroom tissue or soft cloth before applying
    • apply externally to the area up to 6 times daily or after bowel movment
    • After application, discard pad. Do not flush in toilet.
  • Other Information

    • Store at 20 o-25 oC(68 o-77 o F)
    • Avoid excessive heat and humidity.
  • Inactive Ingredients

    Cetomacrogol 1000, Cetostearyl Alcohol, Chloracresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

  • Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    PROCURE 
    hydrocortisone acetate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-224-02144 in 1 BOX02/05/2013
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:55681-224-0328.3 g in 1 TUBE; Type 0: Not a Combination Product08/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/05/2013
    Labeler - TWIN MED, LLC (009579330)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!