PREMIER VALUE HEMORRHOIDAL- mineral oil, petrolatum, and phenylephrine hydrochloride ointment 
Chain Drug Consortium, 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.

----------

Active ingredients                                                                 Purpose

Mineral Oil 14%................................................................ Protectant

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

Phenylephrine HCI 0.25%................................................... Vasconstrictor

Uses

Warnings

For external and/or intrarectal use only

Ask a doctor or pharmacist before use if you are now 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 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

Inactive ingredients

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

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101

BOCA RATON, FL 33431

MADE IN KOREA

image description

PREMIER VALUE HEMORRHOIDAL 
mineral oil, petrolatum, and phenylephrine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-840
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 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)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-840-571 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/11/2015
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 2/2015
Document Id: ab420d30-d77f-450f-8b81-24bb567fa34c
Set id: 773954b4-0da3-4894-809b-dc61cd557502
Version: 1
Effective Time: 20150211
 
Chain Drug Consortium, LLC