HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hci ointment 
Chain Drug Marketing Association Inc.

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.

----------

Quality 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 intrarectal use only

Ask doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

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.

Ask doctor before use

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

Ask doctor before use if you have:

Directions

Other Information

Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerin, Methylparaben, Laureth-23, Propylparaben, Stearyl alcohol

Questions or Comments?

1-800-935-2362

Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H.

Packaging

hemorrhoid-ointment 2oz

HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-684
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
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
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LAURETH-23 (UNII: N72LMW566G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-684-021 in 1 BOX08/14/2020
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 finalpart34608/14/2020
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 5/2023
Document Id: fc5f831c-169e-de28-e053-6394a90a8f1f
Set id: acdc76b4-166b-ee8d-e053-2a95a90aa359
Version: 3
Effective Time: 20230523
 
Chain Drug Marketing Association Inc.