Drug Facts

Active ingredients

Phenylephrine hydrochloride 0.25%

Witch hazel 50.0%

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)

LEADER
phenylephrine hydrochloride and witch hazel cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/28/2014

Labeler - Cardinal Health (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
Natural Essentials		947484713	MANUFACTURE(49781-091)