LEADER HEMORRHOIDAL - mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointment 
CARDINAL HEALTH

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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Drug Facts

Active ingredients                                                              Purpose

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

Petrolatum 71.9% .............................................................Protectant

Phenylephrine HCL 0.25% .................................................Vasoconstrictor

Shark liver oil 3.0% ...........................................................Protectant

Uses

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

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 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 20o to 25oC (68o to 77oF)

Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

BHA, concentrated glycerin, glyceryl monosterarte, methylparaben, propylparaben, purified lanoline, purified water, thyme oil red

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN2312940

www.myleader.com

1-800-200-6313

Made in Korea

image of carton labelEnter section text here

LEADER HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-405
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) PETROLATUM719 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
SHARK LIVER OIL (UNII: 4B24275HEU) (SHARK LIVER OIL - UNII:4B24275HEU) SHARK LIVER OIL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
THYME OIL (UNII: 2UK410MY6B)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-405-161 in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/01/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 5/2012
Document Id: ece7db10-e0ae-40e3-a4be-c1f03a9dbb38
Set id: 855ab0c0-5e1c-4f75-b1c4-b8669d16bde4
Version: 1
Effective Time: 20120501
 
CARDINAL HEALTH