LEADER- glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, PJ Noyes Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Glycerin 14.4%

Petrolatum 15%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

Purposes

Protectant

Protectant

Vasoconstrictor

Local anesthetic

Uses

• helps relieve local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• temporarily relieves burning
• aids in protecting irritated anorectal areas

Warnings

For external use only

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are presently 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
• do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• bleeding occurs
• condition gets worse or does not improve within 7 days

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults: when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying
• when first opening the tube, puncture foil seal with top end of cap
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• Children under 12 years of age: ask a doctor

Other information

• store at 20° - 25°C (68°-77°F)
• for lot number and expiration date, see crimp of tube or see box

Inactive ingredients

cetearyl alcohol, cetyl alcohol, glycerol monostearate, mineral oil, peg 40 castor oil, propylene glycol, purified water, stearyl alcohol, tocopheryl acetate (Vitamin E)

Principal Display Panel - Carton Label

NDC: 49781-090-01

LEADER®

MAXIMUM STRENGTH

Hemorrhoidal Cream

Rapid soothing pain relief from burning, itching and discomfort Protects irritated tissue

NET WT 1 OZ (28g)

Principal Display Panel - Tube Label

NDC: 49781-090-01

LEADER®

MAXIMUM STRENGTH

Hemorrhoidal Cream

Rapid soothing pain relief from burning, itching and discomfort Protects irritated tissue

NET WT 1 OZ (28g)

INGREDIENTS AND APPEARANCE

LEADER 
glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-090
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	144 mg  in 1 L
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	150 mg  in 1 L
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg  in 1 L
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Mineral Oil (UNII: T5L8T28FGP)
Peg-40 Castor Oil (UNII: 4ERD2076EF)
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
.ALPHA.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-090-01	1 in 1 CARTON	04/28/2014
1		0.028 L in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/28/2014

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
PJ Noyes Company		018927392	MANUFACTURE(49781-090)