QUALITY CHOICE HEMORRHOIDAL- mineral oil ointment 
Chain Drug Marketing Association

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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QC Hemorrhoidal Ointment 2oz (with applicator) NBE Preparation H 95128

Active ingredients                                                              Purpose

Mineral oil 14%................................................................Protectant

Petrolatum 74.9%............................................................Protectant

Phenylephrine HCl 0.25%..........................................Vasoconstrictor

Uses

Warnings For external and/or intrarectal use only

Ask a doctor before use if you have

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

When using this product do not use more than the recommended daily dosage

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a physician 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° to 25°C (68° to 77°F)

Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Distributed by:

C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Made in Korea

image description

QUALITY CHOICE HEMORRHOIDAL 
mineral oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-201
Route of AdministrationTOPICAL, RECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
THYME OIL (UNII: 2UK410MY6B)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-201-021 in 1 CARTON10/12/2016
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 finalpart34606/30/2013
Labeler - Chain Drug Marketing Association (011920774)

Revised: 12/2019
Document Id: 98fee9e3-2843-779b-e053-2a95a90a6b94
Set id: 189db75e-0e19-4379-a0e6-1d0493e5d154
Version: 5
Effective Time: 20191205
 
Chain Drug Marketing Association