PROCURE- hydrocortisone acetate ointment 
TWIN MED, LLC

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Drug Facts

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

Other Information

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

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)

Revised: 1/2024
Document Id: 0e7170c6-aa4c-73ff-e063-6294a90a2d00
Set id: 2670c9c4-66ad-40e8-a08a-582b160de39d
Version: 12
Effective Time: 20240108
 
TWIN MED, LLC