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hemorrhoidal

Western Family Foods Inc

Western Family Hemorrhoidal Cream Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Purpose

Protectant

Vasoconstrictor

Local anesthetic

hemorrhoidal 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

HEMORRHOIDAL CREAM

with MAXIMUM STRENGTH PAIN RELIEF

Smooth Cream Formula with Aloe

Prompt Soothing Relief from Painful Burning, Itching and Discomfort

Shrinks Swollen Hemorrhoidal Tissue

Protects Irritated Tissue

Relieves External Discomfort

COMPARE TO THE ACTIVE INGREDIENTS OF PREPARATION H® CREAM

hemorrhoidal

glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-944
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GLYCERIN 14.4 g
Phenylephrine Hydrochloride PHENYLEPHRINE 0.25 g
pramoxine hydrochloride PRAMOXINE 1 g
petrolatum 15 g

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
BUTYLATED HYDROXYANISOLE
CARBOXYMETHYLCELLULOSE SODIUM
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
laureth-23
METHYLPARABEN
Mineral Oil
PANTHENOL
PROPYL GALLATE
PROPYLPARABEN
water
SODIUM BENZOATE
STEARETH-2
Steareth-20
stearyl alcohol
.ALPHA.-TOCOPHEROL
XANTHAN GUM

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 51 in 1 TUBE
2 NDC:55312-944-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2012-09-24


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