Rite Aid Corporation Hemorrhoidal Cream Drug Facts

Rite Aid Corporation Hemorrhoidal Cream Drug Facts
SPL v4
SPL
SPL Set ID 407c78ca-6fee-4ed6-b61b-711ec049c86e
Route
TOPICAL
Published
Effective Date 2024-08-15
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 Completed Since 2020-02-27 Until 2022-07-31

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
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?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients of Preparation H® Cream

MAXIMUM STRENGTH PAIN RELIEF

HEMORRHOIDAL CREAM

SMOOTH CREAM FORMULA

rapid soothing pain relief from painful burning, itching & discomfort

shrinks swollen hemorrhoidal tissue

protects irritated tissue

relieves external discomfort

WITH ALOE

NET WT 1.8 OZ (51 g)

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. (1-800-222-1222)

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
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?)

1-800-719-9260

Principal Display Panel

Compare to the active ingredients of Preparation H® Cream

MAXIMUM STRENGTH PAIN RELIEF

HEMORRHOIDAL CREAM

SMOOTH CREAM FORMULA

rapid soothing pain relief from painful burning, itching & discomfort

shrinks swollen hemorrhoidal tissue

protects irritated tissue

relieves external discomfort

WITH ALOE

NET WT 1.8 OZ (51 g)

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. (1-800-222-1222)

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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