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

LEADER HEMORRHOIDAL by

Drug Labeling and Warnings

LEADER HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                              Purpose

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

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

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

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

PURPOSE

Uses

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue and relieves burning
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  

WARNINGS

Warnings

For external and/or intrarectal use only

ASK DOCTOR

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
  

ASK DOCTOR/PHARMACIST

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

WHEN USING

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

STOP USE

Stop use and ask a doctor if

• bleeding occurs
• condition gets worse or does not get better within 7 days
• introduction of the applicator into the rectum causes additional pain
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a physician before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• children under 12 years of age: ask a doctor
  
• adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
• gently dry by patting or blotting with a tissue or a soft cloth before applying
• when first opening tube, remove foil seal
• for intrarectal use: remove protective cover form applicator and attach to tube
  
• lubricate applicator well, then gently insert applicator into the rectum
• thoroughly clean applicator and replace protective cover after each use
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• also apply ointment to external area
  

STORAGE AND HANDLING

Other information

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

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

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN2312940

www.myleader.com

1-800-200-6313

Made in Korea

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	719 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g
SHARK LIVER OIL (UNII: 4B24275HEU) (SHARK LIVER OIL - UNII:4B24275HEU)	SHARK LIVER OIL	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-405-16	1 in 1 CARTON
1		56 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	05/01/2012

Labeler - CARDINAL HEALTH (097537435)