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Leader by Cardinal Health

Medically reviewed on January 24, 2018

Dosage form: cream
Ingredients: Glycerin 144mg in 1L, Petrolatum 150mg in 1L, Phenylephrine Hydrochloride 2.5mg in 1L, Pramoxine Hydrochloride 10mg in 1L
Labeler: Cardinal Health
NDC Code: 49781-090

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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)

LEADER 
glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-090
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (Glycerin) Glycerin144 mg  in 1 L
Petrolatum (Petrolatum) Petrolatum150 mg  in 1 L
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 1 L
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride10 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf 
Cetostearyl Alcohol 
Cetyl Alcohol 
Glyceryl Monostearate 
Mineral Oil 
Peg-40 Castor Oil 
Water 
Propylene Glycol 
Stearyl Alcohol 
.ALPHA.-Tocopherol Acetate 
Packaging
#Item CodePackage Description
1NDC:49781-090-011 TUBE in 1 CARTON
10.028 L in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/28/2014
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
PJ Noyes Company018927392MANUFACTURE(49781-090)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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