FDA Label for Leader

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENTS
PURPOSES
USES
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - ASK DOCTOR/PHARMACIST
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
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PRINCIPAL DISPLAY PANEL - TUBE LABEL

Leader Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Active Ingredients

Glycerin 14.4%

Petrolatum 15%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

Purposes

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

Otc - Ask Doctor/Pharmacist

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.

Otc - 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.

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 - Carton Label - lea00 0000 01

Principal Display Panel - Tube Label