Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 24bc9e60-28ee-4669-8707-f6b91016d737

Route

TOPICAL

Published

Effective Date 2010-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Phenylephrine (0.25 g) Witch Hazel (50 g)

Inactive Ingredients

Aloe Vera Leaf Sulisobenzone Edetate Disodium Hydroxyethyl Cellulose (2000 Cps At 1%) Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Sodium Citrate .alpha.-tocopherol Acetate, D- Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2006-11-15

Description

Phenylephrine HCI, 0.25% Witch Hazel, 50.0%

Purpose

Vasoconstrictor Astringent

Medication Information

Warnings and Precautions

Purpose

Vasoconstrictor

Astringent

Description

Phenylephrine HCI, 0.25% Witch Hazel, 50.0%

Uses

Helps relieve the local itching and discomfort associated with hemorrhoids
Temporary relief of irritation and burning
Temporarily shrinks hemorrhoidal tissue
Aids in protecting irritated anorectal areas

Section 42229-5

Section 50570-1

Section 53413-1

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 gel.
When first opening the tube, puncture foil seal with top end of cap
Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement

Children under 12 years: ask a doctor.

Active Ingredient

Phenylephrine HCI, 0.25%

Witch Hazel, 50.0%

Other Information

Store at room temperature: 20° - 25° C (68° - 77° F)

Inactive Ingredients

aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor
do not put into the rectum 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

Package Information Tube

Sunmark®

COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*

NDC 49348-811-32

Hemorrhoidal Cooling Gel

Fast Cooling Relief

WITH VITAMIN E AND ALOE

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.

Distributed by McKesson

One Post Street

San Francisco, CA 94104

Money Back Guarantee

Package Information Carton

Sunmark®

COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*

NDC 49348-811-32

Hemorrhoidal Cooling Gel

Fast Cooling Relief

Clear, non-greasy formula with no unpleasant scent

Prompt cooling relief from painful burning and itching

WITH VITAMIN E AND ALOE

NET WT. 1.8 OZ (51 g)

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.

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

If Pregnant Or Breastfeeding,

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.

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)

Helps relieve the local itching and discomfort associated with hemorrhoids
Temporary relief of irritation and burning
Temporarily shrinks hemorrhoidal tissue
Aids in protecting irritated anorectal areas

Warnings and Precautions (34071-1)

Section 42229-5 (42229-5)

Section 50570-1 (50570-1)

Section 53413-1 (53413-1)

Purpose (PURPOSE)

Vasoconstrictor

Astringent

Warnings (WARNINGS)

For external use only.

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 a soft cloth before applying gel.
When first opening the tube, puncture foil seal with top end of cap
Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement

Children under 12 years: ask a doctor.

Active Ingredient (ACTIVE INGREDIENT)

Phenylephrine HCI, 0.25%

Witch Hazel, 50.0%

Other Information (OTHER INFORMATION)

Store at room temperature: 20° - 25° C (68° - 77° F)

Inactive Ingredients (INACTIVE INGREDIENTS)

aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water

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 using fingers or any mechanical device or applicator

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

if bleeding occurs
condition worsens or does not improve within 7 days

Package Information Tube (PACKAGE INFORMATION - TUBE)

Sunmark®

COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*

NDC 49348-811-32

Hemorrhoidal Cooling Gel

Fast Cooling Relief

WITH VITAMIN E AND ALOE

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.

Distributed by McKesson

One Post Street

San Francisco, CA 94104

Money Back Guarantee

Package Information Carton (PACKAGE INFORMATION - CARTON)

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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.

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

[{"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULISOBENZONE", "unii": "1W6L629B4K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)", "unii": "S38J6RZN16", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WITCH HAZEL", "unii": "101I4J0U34", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"USES": "Helps relieve the local itching and discomfort associated with hemorrhoids Temporary relief of irritation and burning Temporarily shrinks hemorrhoidal tissue Aids in protecting irritated anorectal areas", "PURPOSE": "Vasoconstrictor Astringent", "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 gel. When first opening the tube, puncture foil seal with top end of cap Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement Children under 12 years: ask a doctor.", "ACTIVE INGREDIENT": "Phenylephrine HCI, 0.25% Witch Hazel, 50.0%", "OTHER INFORMATION": "Store at room temperature: 20° - 25° C (68° - 77° F)", "INACTIVE INGREDIENTS": "aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water", "When using this product": "do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum 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", "PACKAGE INFORMATION - TUBE": "Sunmark® COMPARE TO PREPARATION H® ACTIVE INGREDIENTS* NDC 49348-811-32 Hemorrhoidal Cooling Gel Fast Cooling Relief WITH VITAMIN E AND ALOE 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. Distributed by McKesson One Post Street San Francisco, CA 94104 Money Back Guarantee", "PACKAGE INFORMATION - CARTON": "Sunmark® COMPARE TO PREPARATION H® ACTIVE INGREDIENTS* NDC 49348-811-32 Hemorrhoidal Cooling Gel Fast Cooling Relief Clear, non-greasy formula with no unpleasant scent Prompt cooling relief from painful burning and itching WITH VITAMIN E AND ALOE NET WT. 1.8 OZ (51 g) Another Quality Product Distributed by McKesson One Post Street, San Francisco, CA 94104 Money Back Guarantee Please visit us at www.sunmarkbrand.com FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.", "If pregnant or breastfeeding,": "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.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.120962 · Updated: 2026-03-14T22:52:17.029964