LEADER HEMORRHOLIDAL- mineral oil, petrolatum, phenylephrine hydrochloride 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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Leader Hemorrhoidal Ointment 2 oz. w/ applicator NBE Preperation H

Active Ingredients                                    Purpose

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

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

Phenylephrine HCI 0.25%...........................Vasoconstrictor

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

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, alchohol, thyme oil, tocopherol acetate, water, white wax

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OH 43017 USA

Made in Korea

image description

LEADER HEMORRHOLIDAL 
mineral oil, petrolatum, phenylephrine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-077
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)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-077-021 in 1 CARTON12/10/2013
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 finalpart34612/10/2013
Labeler - Cardinal Health (097537435)

Revised: 12/2017
Document Id: 601add8a-fa6f-f308-e053-2a91aa0a6b4f
Set id: f5bd4007-75f8-40ef-ba32-8eba475847e1
Version: 3
Effective Time: 20171211
 
Cardinal Health