HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment 
Trifecta Pharmaceuticals USA LLC

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Hemorrhoidal Ointment

Drug Facts

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Mineral Oil 14%

Purpose

Protectant

Active Ingredient

Petrolatum 74.9%

Purpose

Protectant

Uses

Warnings

For external and/or anorectal use only

Ask doctor before use if you have

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

Stop Use and Ask Doctor if

If Pregnant or Breast-Feeding

Ask a doctor before use

Keep out of reach of children

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

Directions

Adults and children 12 years of age and older for topical use:

Children under 12 years of age: ask a doctor before use

Other Information

Questions? Call 1-888-296-9067

Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

Distributed By:

Trifecta Pharamceuticals USA, LLC.®

101 NE Third Ave. Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

4042 HEMORRHOIDAL OINTMENT 2OZ UPC REV14 050923 CDER

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-020
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
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WHITE WAX (UNII: 7G1J5DA97F)  
THYME OIL (UNII: 2UK410MY6B)  
LANOLIN (UNII: 7EV65EAW6H)  
GLYCERIN (UNII: PDC6A3C0OX)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-020-021 in 1 BOX05/04/2017
156 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-020-011 in 1 BOX09/14/2020
228.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01505/04/2017
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 12/2024
Document Id: 298d8c06-797d-7cc0-e063-6394a90a3e43
Set id: 4eb3c9ac-268a-5246-e054-00144ff88e88
Version: 8
Effective Time: 20241218
 
Trifecta Pharmaceuticals USA LLC