Hemorrhoidal Pain Relief Cream

Hemorrhoidal Pain Relief Cream
SPL v2
SPL
SPL Set ID 374dc1c0-4243-b272-e063-6394a90a5a6b
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11

Description

Active Ingredients Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% Petrolatum 15%


Medication Information

Description

Active Ingredients Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% Petrolatum 15%

Uses
  • For temporary relief from pain and burning
  • Helps relieve 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
Section 51945-4

Warnings:

For external use only

Important:

Please do not discard this printed box and any enclosed printed material.

The inside final product may not have all the details you require for the ongoing use of the product.

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 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 using cream from the tube, then gently insert dispensing cap partway into anus. Thoroughly cleanse dispensing cap after each use and replace cover.
  • Children under 12 years of age: ask a doctor.
Drug Facts:

Active Ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

Petrolatum 15%

Other Information:

storage temperature: not to exceed 30°C (86°F). Protect from freezing.

Inactive Ingredients:

Aloe vera leaf, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate

Questions Or Comments?

1 (877) 477-8633

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

When Using This Product:
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Do not put in the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask Doctor If:
  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
  • An allergic reaction occurs
  • 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
  • Difficulty in urination due to enlargement of 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 from pain and burning
  • Helps relieve 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
Section 51945-4 (51945-4)

Warnings:

For external use only

Important:

Please do not discard this printed box and any enclosed printed material.

The inside final product may not have all the details you require for the ongoing use of the product.

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 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 using cream from the tube, then gently insert dispensing cap partway into anus. Thoroughly cleanse dispensing cap after each use and replace cover.
  • Children under 12 years of age: ask a doctor.
Drug Facts:

Active Ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

Petrolatum 15%

Other Information: (Other information:)

storage temperature: not to exceed 30°C (86°F). Protect from freezing.

Inactive Ingredients: (Inactive ingredients:)

Aloe vera leaf, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate

Questions Or Comments? (Questions or comments?)

1 (877) 477-8633

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

When Using This Product: (When using this product:)
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Do not put in the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask Doctor If: (Stop use and ask doctor if:)
  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
  • An allergic reaction occurs
  • 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
  • Difficulty in urination due to enlargement of 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.


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Raw Label Data

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