Leader description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Leader

Cardinal Health


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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)

Leader

phenylephrine hydrochloride and witch hazel CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49781-091
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
WITCH HAZEL 500 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
EDETATE DISODIUM
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
METHYLPARABEN
polysorbate 80
propylene glycol
PROPYLPARABEN
water
SODIUM CITRATE
.ALPHA.-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.026 in 1 TUBE
2 NDC:49781-091-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2014-04-28


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.