Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0dea93da-f123-4b01-b821-85ea3cd61423
Routes
RECTAL TOPICAL
Published
Effective Date 2010-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.144 mg) Phenylephrine (0.0025 mg) Pramoxine (0.01 mg) Petrolatum (0.15 mg)
Inactive Ingredients
Aloe Vera Leaf Butylated Hydroxyanisole Carboxymethylcellulose Sodium Cetyl Alcohol Anhydrous Citric Acid Edetate Disodium Glyceryl Monostearate Laureth-23 Methylparaben Light Mineral Oil Panthenol Propyl Gallate Propylene Glycol Propylparaben Water Sodium Benzoate Stearyl Alcohol Alpha-tocopherol .alpha.-tocopherol Acetate, Dl- Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-04-01
Description

Glycerin, USP 14.4% Phenylephrine HCI, 0.25% Pramoxine HCI, 1% White petrolatum, 15%

Purpose

Protectant Vasoconstrictor Local anesthetic Protectant

Medication Information

Warnings and Precautions



Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Description

Glycerin, USP 14.4% Phenylephrine HCI, 0.25% Pramoxine HCI, 1% White petrolatum, 15%

Uses
  • Temporarily relieves 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

Section 42229-5



Section 50570-1


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 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 applicator well, then gently insert applicator into the rectum.
  • Thoroughly clean dispensing cap after each use and replace cover

Children under 12 years:  ask a doctor.
Questions?

Call 1-800-910-6874

Other Information
Store at room temperature: 20° - 25° C (68° - 77° F)
Active Ingredients
Glycerin, USP 14.4%



Phenylephrine HCI, 0.25%



Pramoxine HCI, 1%



White petrolatum, 15%

Inactive Ingredients
aloe barbadensis leaf extract, BHA, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopherol. vitamin E, xanthan gum

When Using This Product
do not exceed the recommended daily dosage unless directed by a doctor

Package Information Box

up and up



NDC 11673-572-24



Hemorrhoidal Cream

maximum strength



Compare to Preparation H® Hemorrhoidal Cream*



Helps shrink swelling of irritated hemorrhoidal tissues



NET WT 1.8 OZ (51 g)



DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED.



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



Distributed by Target Corporation

Minneapolis, MN 55403

Made in U.S.A.



® and © 2009 Target Brands, Inc.

All Rights Reserved

Shop Target.com





Package Information Tube
up and up



NDC 11673-572-24



Hemorrhoidal Cream

maximum strength



Compare to Preparation H® Hemorrhoidal Cream*



Helps shrink swelling of irritated hemorrhoidal tissues



NET WT 1.8 OZ (51 g)



This tube is sealed and packaged in a carton. Do not buy if carton is missing . Do not use if the seal under the cap has been punctured or if the tube is damaged.



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



Dist. by Target Corp.

Minneapolis, MN 55403

Made in U.S.A.



® and © 2009 Target Brands, Inc.

All Rights Reserved

Shop Target.com





If Pregnant Or Breastfeeding

 ask a health professional before use.

Stop Use and Ask A Doctor If
  • bleeding occurs
  • the introduction of the applicator causes additional pain
  • 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

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
  • thyroid disease
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the 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 (USES)
  • Temporarily relieves 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 and Precautions (34071-1)



Section 42229-5 (42229-5)



Section 50570-1 (50570-1)


Purpose (PURPOSE)

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Directions (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 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 applicator well, then gently insert applicator into the rectum.
  • Thoroughly clean dispensing cap after each use and replace cover

Children under 12 years:  ask a doctor.
Questions?

Call 1-800-910-6874

Other Information (OTHER INFORMATION)
Store at room temperature: 20° - 25° C (68° - 77° F)
Active Ingredients (ACTIVE INGREDIENTS)
Glycerin, USP 14.4%



Phenylephrine HCI, 0.25%



Pramoxine HCI, 1%



White petrolatum, 15%

Inactive Ingredients (INACTIVE INGREDIENTS)
aloe barbadensis leaf extract, BHA, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopherol. vitamin E, xanthan gum

When Using This Product (When using this product)
do not exceed the recommended daily dosage unless directed by a doctor

Package Information Box (PACKAGE INFORMATION - BOX)

up and up



NDC 11673-572-24



Hemorrhoidal Cream

maximum strength



Compare to Preparation H® Hemorrhoidal Cream*



Helps shrink swelling of irritated hemorrhoidal tissues



NET WT 1.8 OZ (51 g)



DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED.



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



Distributed by Target Corporation

Minneapolis, MN 55403

Made in U.S.A.



® and © 2009 Target Brands, Inc.

All Rights Reserved

Shop Target.com





Package Information Tube (PACKAGE INFORMATION - TUBE)
up and up



NDC 11673-572-24



Hemorrhoidal Cream

maximum strength



Compare to Preparation H® Hemorrhoidal Cream*



Helps shrink swelling of irritated hemorrhoidal tissues



NET WT 1.8 OZ (51 g)



This tube is sealed and packaged in a carton. Do not buy if carton is missing . Do not use if the seal under the cap has been punctured or if the tube is damaged.



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



Dist. by Target Corp.

Minneapolis, MN 55403

Made in U.S.A.



® and © 2009 Target Brands, Inc.

All Rights Reserved

Shop Target.com





If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

 ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • the introduction of the applicator causes additional pain
  • 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

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
  • thyroid disease
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.093757 · Updated: 2026-03-14T22:52:17.029964