LEADER- glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream 
Cardinal Health

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.

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Drug Facts

Active ingredients

Glycerin 14.4%

Petrolatum 15%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

Purposes

Protectant

Protectant

Vasoconstrictor

Local anesthetic

Uses

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

Other information

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

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)

Principal Display Panel - Tube Label
LEADER 
glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-090
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin144 mg  in 1 L
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum150 mg  in 1 L
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 1 L
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Mineral Oil (UNII: T5L8T28FGP)  
Peg-40 Castor Oil (UNII: 4ERD2076EF)  
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
.ALPHA.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-090-011 in 1 CARTON04/28/2014
10.028 L in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/28/2014
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIBusiness Operations
PJ Noyes Company018927392MANUFACTURE(49781-090)

Revised: 1/2018
Document Id: 2dcad275-3d50-42a1-a7b4-2fd0d1878039
Set id: 4e832b05-d3dc-4ffb-bdcc-9ffb983fbc08
Version: 2
Effective Time: 20180124
 
Cardinal Health