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hemorrhoidal

Meijer Distribution Inc

Meijer Distribution, Inc. Hemorrhoidal Cream Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Questions or comments? 1-800-719-9260

Principal Display Panel

Compare to Preparation H® Cream active ingredients

Maximum Strength Pain Relief

Hemorrhoidal Cream

Smooth Cream Formula with Aloe

hemorrhoidal
Hemorrhoidal Cream Carton Image 1 Hemorrhoidal Cream Carton Image 2

hemorrhoidal

glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-944
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:41250-944-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2008-02-06


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Be sure to consult your doctor before taking any medication!
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