HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment 
Pharmacy Value Alliance, LLC

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.

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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 or depression

When using this product do not exceed the recommended daily dosage unless directed by a doctor

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

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

Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe

Other Information

Store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Beeswax, benzolc acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, stearyl alcohol

Distributed by:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Hemorrhoidal Ointment

Packaging

Hemorrhoid Ointment

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-528
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
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
THYME OIL (UNII: 2UK410MY6B)  
WHITE WAX (UNII: 7G1J5DA97F)  
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-528-001 in 1 BOX07/19/2016
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/19/2016
Labeler - Pharmacy Value Alliance, LLC (101668460)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 3/2023
Document Id: f5edb656-4f7f-2386-e053-2995a90a70de
Set id: 3803a61b-308a-14a9-e054-00144ff88e88
Version: 4
Effective Time: 20230302
 
Pharmacy Value Alliance, LLC