Supervalu Inc. Hemorrhoidal Cream Drug Facts

Supervalu Inc. Hemorrhoidal Cream Drug Facts
SPL v6
SPL
SPL Set ID bf87824a-522d-46da-81b6-e30ea11a2235
Route
TOPICAL
Published
Effective Date 2021-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (14.4 g) Phenylephrine (0.25 g) Pramoxine (1 g) Petrolatum (15 g)
Inactive Ingredients
Aloe Vera Leaf Butylated Hydroxyanisole Carboxymethylcellulose Sodium, Unspecified 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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-03-28

Description

Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% White petrolatum 15%

Purpose

Protectant Vasoconstrictor Local anesthetic


Medication Information

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Description

Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% White petrolatum 15%

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

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)
Active Ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

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?

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to Preparation H® Cream active ingredients

hemorrhoidal cream

• rapid soothing pain relief from painful burning, itching and discomfort

• shrinks swollen hemorrhoidal tissue • protects irritated tissue

• relieves external discomfort

maximum strength pain relief • smooth cream formula with aloe

NET WT 1.8 OZ (51g)

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.

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


Structured Label Content

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
Purpose

Protectant

Vasoconstrictor

Local anesthetic

Warnings

For external use only

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 (Other information)
  • store at 20°-25°C (68°-77°F)
Active Ingredients (Active ingredients)

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Inactive Ingredients (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? (Questions or comments?)

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to Preparation H® Cream active ingredients

hemorrhoidal cream

• rapid soothing pain relief from painful burning, itching and discomfort

• shrinks swollen hemorrhoidal tissue • protects irritated tissue

• relieves external discomfort

maximum strength pain relief • smooth cream formula with aloe

NET WT 1.8 OZ (51g)

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression


Advanced Ingredient Data


Raw Label Data

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