HEMORRHOIDALCREAMPROCURE- phenylephrine hcl, petrolatum, mineral oil cream 
TWIN MED, LLC

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PROCURE Hemorrhoidal Cream

Drug Facts

Mineral Oil (14% w/w)............................................. Skin Protectant

Petrolatum (74.9% w/w)........................................... Skin Protectant


Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor

Uses

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, PEG-40 Hydrogenated Castor Oil, PEG-100 Stearate, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax

PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

HEMORRHOIDALCREAMPROCURE 
phenylephrine hcl, petrolatum, mineral oil cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WHITE WAX (UNII: 7G1J5DA97F)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CORN OIL (UNII: 8470G57WFM)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-410-5556.6 g in 1 TUBE; Type 0: Not a Combination Product10/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01510/05/2022
Labeler - TWIN MED, LLC (009579330)

Revised: 1/2024
Document Id: 0e71885d-e860-73f9-e063-6294a90a1213
Set id: e9c44756-1c98-41be-e053-2995a90a35b4
Version: 4
Effective Time: 20240108
 
TWIN MED, LLC