Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4

Route

TOPICAL

Published

Effective Date 2022-12-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Phenylephrine (2.5 mg) Witch Hazel (500 mg)

Inactive Ingredients

Aloe Vera Leaf Edetate Disodium Hydroxyethyl Cellulose (140 Mpa.s At 5%) Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sulisobenzone .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2004-01-01

Description

Phenylephrine HCl 0.25% Witch hazel 50.0%

Purpose

Vasoconstrictor Astringent

Medication Information

Purpose

Vasoconstrictor Astringent

Description

Phenylephrine HCl 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

Purposes

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 of age: ask a doctor

Other Information

store at 20-25°C (68-77°F)

Active Ingredients

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Inactive Ingredients

aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate

Additional Information

Do Not Use if tube seal under cap embossed with “H” is broken or missing.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.preparationh.com

Trademarks owned or licensed by GSK

Made In Canada

Do Not Use if tube seal under cap embossed with “H” is broken or missing.

Questions Or Comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

Principal Display Panel

PREPARATION H

HEMORRHOIDAL

COOLING

GEL

Fast Cooling

Relief

Clear, Non-Greasy Formula with

No Unpleasant Scent
Prompt, Cooling Relief from Painful

Burning & Itching
Shrinks Swollen Hemorrhoidal Tissue
Relieves External Discomfort

1 TUBE | NET WT 1.8 OZ (51 g)

PAA162794 Front Carton

When Using This Product

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

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
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

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

Purposes

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 of age: ask a doctor

Other Information (Other information)

store at 20-25°C (68-77°F)

Active Ingredients (Active ingredients)

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate

Additional Information (Additional information)

Do Not Use if tube seal under cap embossed with “H” is broken or missing.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.preparationh.com

Trademarks owned or licensed by GSK

Made In Canada

Do Not Use if tube seal under cap embossed with “H” is broken or missing.

Questions Or Comments? (Questions or comments?)

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PREPARATION H

HEMORRHOIDAL

COOLING

GEL

Fast Cooling

Relief

Clear, Non-Greasy Formula with

No Unpleasant Scent
Prompt, Cooling Relief from Painful

Burning & Itching
Shrinks Swollen Hemorrhoidal Tissue
Relieves External Discomfort

1 TUBE | NET WT 1.8 OZ (51 g)

PAA162794 Front Carton

When Using This Product (When using this product)

do not exceed the recommended daily dosage unless directed by a doctor
do not put this product into the rectum by using fingers or any mechanical device or applicator

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

bleeding occurs
condition worsens or does not improve within 7 days

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.

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 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": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)", "unii": "8136Y38GY5", "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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULISOBENZONE", "unii": "1W6L629B4K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WITCH HAZEL", "unii": "101I4J0U34", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "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", "Purposes": "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 of age: ask a doctor", "Other information": "store at 20-25°C (68-77°F)", "Active ingredients": "Phenylephrine HCl 0.25% Witch hazel 50.0%", "Inactive ingredients": "aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate", "Additional information": "Do Not Use if tube seal under cap embossed with “H” is broken or missing. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 For most recent product information, visit www.preparationh.com Trademarks owned or licensed by GSK ©2021 GSK or licensor Made In Canada Do Not Use if tube seal under cap embossed with “H” is broken or missing.", "Questions or comments?": "Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374", "PRINCIPAL DISPLAY PANEL": "PREPARATION H HEMORRHOIDAL COOLING GEL Fast Cooling Relief Clear, Non-Greasy Formula with No Unpleasant Scent Prompt, Cooling Relief from Painful Burning & Itching Shrinks Swollen Hemorrhoidal Tissue Relieves External Discomfort 1 TUBE | NET WT 1.8 OZ (51 g) PAA162794 Front Carton", "When using this product": "do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by 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 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.", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:55.864359 · Updated: 2026-03-14T23:02:45.179164