LEADER- phenylephrine hydrochloride and witch hazel cream

Leader by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Phenylephrine hydrochloride 0.25%

Witch hazel 50.0%

PURPOSE

Vasoconstrictor

Astringent

Uses

• temporarily relieves irritation and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• 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
• 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 occur
• 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 gel
• 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 at20°-25°C (68°-77°F)
• for lot number and expiration date, see crimp of tube or see box

Inactive ingredients

aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)

Principal Display Panel - Carton Label

NDC: 49781-091-01

LEADER®

Hemorrhoidal Cooling Gel

Relief from intense burning & itching

Relieves external discomfort

Enriched with Aloe

NET WT 0.9 OZ (26g)

INGREDIENTS AND APPEARANCE

LEADER 
phenylephrine hydrochloride and witch hazel cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-091
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	2.5 mg  in 1 L
witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34)	witch hazel	500 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
edetate disodium (UNII: 7FLD91C86K)
hydroxyethyl cellulose (100 mpa.s at 2%) (UNII: R33S7TK2EP)
methylparaben (UNII: A2I8C7HI9T)
polysorbate 80 (UNII: 6OZP39ZG8H)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium citrate (UNII: 1Q73Q2JULR)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-091-01	1 in 1 CARTON	04/28/2014
1		0.026 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
Natural Essentials		947484713	MANUFACTURE(49781-091)