GOOD SENSE HEMORRHOIDAL CREAM MAXIMUM STRENGTH PAIN RELIEF- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride and petrolatum cream 
L Perrigo Company

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.

----------

Perrigo Hemorrhoidal Cream Drug Facts

Active ingredient

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

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 the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf extract, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, vitamin E, xanthan gum

Principal Display Panel

Maximum Strength Pain Relief

Hemorrhoidal Cream

Smooth Cream Formula with Aloe

Rapid Soothin Pain Relief from Painful Burning, Itching and Discomfort

Shrinks Swollen Hemorrhoidal Tissue{s}

Protects Irritated Tissue{s}

Relieves External Discomfort

Compare to active ingredients of Preparation H® Cream

Hemorrhoidal Cream Carton

Hemorrhoidal Cream Carton

GOOD SENSE HEMORRHOIDAL CREAM  MAXIMUM STRENGTH PAIN RELIEF
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0113-0944
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM15 g  in 100 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0113-0944-241 in 1 CARTON
151 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/28/2008
Labeler - L Perrigo Company (006013346)

Revised: 7/2009
Document Id: 1d6142b6-3746-46f1-99ec-4b19d26f056e
Set id: 1d6142b6-3746-46f1-99ec-4b19d26f056e
Version: 1
Effective Time: 20090717
 
L Perrigo Company