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

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

When using this product

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

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

Inactive Ingredients

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

Questions

Call 1-800-883-0085

Distributed By

Proudly Distributed by

Assocated wholesale grocers inc

kansas city Kansas 66106

Call 1 844 2921112 for product information

www.bestchoicebrand.com

Preparation H is a registered trademark of Glaxosmithkline consumer healthcare holdings US

Best Choice Hemorrhoidal Ointment 2oz 050923 CDER

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-133
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LAURETH-15 (UNII: 002FR4N8OV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-133-201 in 1 BOX06/01/2023
156.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/01/2023
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 6/2023
Document Id: fe18fa61-83fa-8bf9-e053-6294a90a7585
Set id: fe18fa61-83f9-8bf9-e053-6294a90a7585
Version: 1
Effective Time: 20230614
 
Trifecta Pharmaceuticals USA LLC