Hemorrhoidal Cream Maximum Strength Pain Relief

Hemorrhoidal Cream Maximum Strength Pain Relief
SPL v6
SPL
SPL Set ID 804d7b1f-1be8-50c9-e053-2a91aa0a35d0
Route
TOPICAL
Published
Effective Date 2025-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g) Petrolatum (15 g) Glycerin (14.4 g) Phenylephrine (0.25 g)
Inactive Ingredients
Aloe Vera Leaf Glyceryl Monostearate Carboxymethylcellulose Sodium (0.7 Carboxymethyl Substitution Per Saccharide; 100-200 Mpa.s At 1%) Cetyl Alcohol Propylparaben Mineral Oil Polysorbate 80 Propylene Glycol Water Stearic Acid Xanthan Gum Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-25

Description

Glycerol 14.4%

Purpose

Protectant


Medication Information

Purpose

Protectant

Description

Glycerol 14.4%

Uses

Helps relieve the local itching and discomfort associated with hemorrhoids

Temporarily shrinks hemorrhoidal tissue and relieves burning

Temporarily provides a coating for relief of anorectal discomforts

Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Label

Label

Warnings

For External Use Only

Ask doctor brfore use if you have

Heart Disease

Thyroid Disease

Diabetes

Trouble urinating due to an enlarged prostate gland

Ask doctor before use if you are presently taking a prescription 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

Packaging

Directions

Adults:

When practical, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

When first opening 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

Distributed By

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

Product of PRC

www.trifecta-pharma.com

Active Ingredient

Glycerol 14.4%

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)

Do not use if tube seal is broken or missing

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®

Inactive Ingredients

Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

Questions Or Comments

Call 1-888-296-9067

Stop Use and Ask A Doctor

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 doctor before use

Keep Out of Reach of Children

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


Structured Label Content

Uses

Helps relieve the local itching and discomfort associated with hemorrhoids

Temporarily shrinks hemorrhoidal tissue and relieves burning

Temporarily provides a coating for relief of anorectal discomforts

Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Label (LABEL)

Label

Purpose

Protectant

Warnings

For External Use Only

Ask doctor brfore use if you have

Heart Disease

Thyroid Disease

Diabetes

Trouble urinating due to an enlarged prostate gland

Ask doctor before use if you are presently taking a prescription 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

Packaging

Directions

Adults:

When practical, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

When first opening 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

Distributed By

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

Product of PRC

www.trifecta-pharma.com

Active Ingredient

Glycerol 14.4%

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)

Do not use if tube seal is broken or missing

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®

Inactive Ingredients

Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

Questions Or Comments (Questions or Comments)

Call 1-888-296-9067

Stop Use and Ask A Doctor (Stop use and ask a doctor)

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 doctor 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


Advanced Ingredient Data


Raw Label Data

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