Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ca59ecb1-2a80-41f3-a0c8-816e1590c611

Route

TOPICAL

Published

Effective Date 2010-01-04

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 2006-08-01

Description

Phenylephrine HCI, 0.25% Witch Hazel, 50%

Purpose

Vasoconstrictor Astringent

Medication Information

Warnings and Precautions

Purpose

Vasoconstrictor

Astringent

Description

Phenylephrine HCI, 0.25% Witch Hazel, 50%

Uses

Helps relieve the local itching and discomfort associated with hemorrhoids
Temporary relief of itching 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%

Other Information

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

Package Information

GOOD NEIGHBOR PHARMACY

NDC 24385-421-06

HEMORRHOIDAL

Cooling Gel

with Vitamin E and Aloe

Fast cooling relief from painful burning and itching

Net Wt. 0.9 oz. (26 g)

Fast cooling relief

Clear, non-greasy formula with no unpleasant scent
Prompt cooling relief from painful burning and itching
Shrinks swollen hemorrhoidal tissue
Relieves external discomfort

*Compare to active ingredients in Preparation H® Cooling Gel

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

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

Distributed By

AmerisourceBergen

Valley Forge, PA 19482-0959

Visit us at www.myGNP.com

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

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

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 itching 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%

Other Information (OTHER INFORMATION)

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

Package Information (PACKAGE INFORMATION)

GOOD NEIGHBOR PHARMACY

NDC 24385-421-06

HEMORRHOIDAL

Cooling Gel

with Vitamin E and Aloe

Fast cooling relief from painful burning and itching

Net Wt. 0.9 oz. (26 g)

Fast cooling relief

Clear, non-greasy formula with no unpleasant scent
Prompt cooling relief from painful burning and itching
Shrinks swollen hemorrhoidal tissue
Relieves external discomfort

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

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

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 itching 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%", "OTHER INFORMATION": "Store at room temperature: 20° - 25° C (68° - 77° F)", "PACKAGE INFORMATION": "GOOD NEIGHBOR PHARMACY NDC 24385-421-06 HEMORRHOIDAL Cooling Gel with Vitamin E and Aloe Fast cooling relief from painful burning and itching Net Wt. 0.9 oz. (26 g) Fast cooling relief Clear, non-greasy formula with no unpleasant scent Prompt cooling relief from painful burning and itching Shrinks swollen hemorrhoidal tissue Relieves external discomfort *Compare to active ingredients in Preparation H® Cooling Gel FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®. Distributed By AmerisourceBergen Valley Forge, PA 19482-0959 Visit us at www.myGNP.com", "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", "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", "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: 2026-02-15T11:54:58.927431 · Updated: 2026-03-14T22:52:14.617580