Walgreens Hemorrhoidal Cream

Walgreens Hemorrhoidal Cream
SPL v2
SPL
SPL Set ID 03bbe146-f185-bcfa-e063-6394a90a85bf
Route
TOPICAL
Published
Effective Date 2023-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (144 mg) Phenylephrine (2.5 mg) Pramoxine (10 mg) Petrolatum (150 mg)
Inactive Ingredients
Glyceryl Monostearate Lanolin Mineral Oil Water Stearic Acid Cetyl Esters Wax Propylparaben Methylparaben Cetostearyl Alcohol Butylated Hydroxyanisole Aloe Vera Leaf Propylene Glycol Cetyl Palmitate Polysorbate 60 Isopropyl Myristate Alpha-tocopherol Acetate Sodium Citrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15

Description

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


Medication Information

Warnings and Precautions

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Indications and Usage

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



Dosage and Administration

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, peel off the foil seal
  • 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
Description

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

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

Section 50567-7

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into rectum by using fingers or any mechanical device or applicator
Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Section 51727-6

Inactive ingredients aloe barbadensis leaf extract, butylated hydroxy anisole, cetostearyl alcohol, cetyl ester wax, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, vitamin E acetate

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Section 55106-9

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Section 60561-8

Other information

  • store at 20-25 °C (68-77 °F)
Warnings

For external use only


Structured Label Content

Indications and Usage (34067-9)

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



Dosage and Administration (34068-7)

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, peel off the foil seal
  • 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
Warnings and Precautions (34071-1)

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into rectum by using fingers or any mechanical device or applicator
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Section 51727-6 (51727-6)

Inactive ingredients aloe barbadensis leaf extract, butylated hydroxy anisole, cetostearyl alcohol, cetyl ester wax, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, vitamin E acetate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Section 55106-9 (55106-9)

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Section 60561-8 (60561-8)

Other information

  • store at 20-25 °C (68-77 °F)
Warnings

For external use only


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)