drug facts

drug facts

SPL v7

SPL

SPL Set ID 2f370875-0225-47b7-b43f-8fa4600d2a0e

Routes

rectal topical

Published

Effective Date 2020-11-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

cocoa butter (2211 mg) phenylephrine (6.25 mg) witch hazel (5 g)

Inactive Ingredients

starch, corn methylparaben propylparaben aloe vera leaf anhydrous citric acid capryl/capramidopropyl betaine diazolidinyl urea glycerin propylene glycol, (r)- water sodium citrate, unspecified form

Identifiers & Packaging

Pill Appearance

Color: yellow Color: white

Marketing Status

otc monograph drug active Since 2015-07-01

Purpose

Protectant Vasoconstrictor

Description

Cocoa butter 88.44% Phenylephrine HCl 0.25%

Medication Information

Warnings

For rectal use only

Uses

helps relieve the local itching and discomfort associated with hemorrhoids
temporarily relieves burning and 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

Purpose

Astringent

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 insertion of this product.
detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:

hold suppository with rounded end up
as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"
slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
remove exposed suppository from wrapper
insert one suppository into the rectum 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)

Inactive Ingredients

corn starch, methylparaben, propylparaben

Description

Cocoa butter 88.44% Phenylephrine HCl 0.25%

Section 42229-5

Preparation H ^®Totables ^®Irritation Relief Wipes

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

bleeding occurs
condition worsens or does not improve within 7 days

Section 50567-7

When using this productdo not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 50569-3

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

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Protectant

Vasoconstrictor

Active Ingredient

Witch hazel 50.0%

Active Ingredients

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Questions Or Comments?

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

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

Principal Display Panel Kit Carton

SAME AMOUNT

Smaller Package

PREPARATION H ^®

HEMORRHOIDAL

SUPPOSITORIES

Provides Relief from

MULTIPLE SYMPTOMS

Reduces Internal Swelling,

Soothes & Protects
Prompt Soothing Relief

from Painful Burning,

Itching and Discomfort
Also for Nighttime Relief

+ 4 FREE

WIPESINSIDE

12 SUPPOSITORIES

Structured Label Content

Warnings

For rectal use only

Uses

helps relieve the local itching and discomfort associated with hemorrhoids
temporarily relieves burning and 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

Purpose

Astringent

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 insertion of this product.
detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:

hold suppository with rounded end up
as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"
slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
remove exposed suppository from wrapper
insert one suppository into the rectum 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)

Inactive Ingredients (Inactive ingredients)

corn starch, methylparaben, propylparaben

Section 42229-5 (42229-5)

Preparation H ^®Totables ^®Irritation Relief Wipes

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

bleeding occurs
condition worsens or does not improve within 7 days

Section 50567-7 (50567-7)

When using this productdo not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Protectant

Vasoconstrictor

Active Ingredient (Active ingredient)

Witch hazel 50.0%

Active Ingredients

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Questions Or Comments? (Questions or comments?)

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

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

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

SAME AMOUNT

Smaller Package

PREPARATION H ^®

HEMORRHOIDAL

SUPPOSITORIES

Provides Relief from

MULTIPLE SYMPTOMS

Reduces Internal Swelling,

Soothes & Protects
Prompt Soothing Relief

from Painful Burning,

Itching and Discomfort
Also for Nighttime Relief

+ 4 FREE

WIPESINSIDE

12 SUPPOSITORIES

Advanced Ingredient Data

[{"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "ACTIB", "strengthNumerator": "2211", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYL/CAPRAMIDOPROPYL BETAINE", "unii": "231H3ZT9NE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL, (R)-", "unii": "602HN5L69H", "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": "WITCH HAZEL", "unii": "101I4J0U34", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps relieve the local itching and discomfort associated with hemorrhoids temporarily relieves burning and 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", "42229-5": "Preparation H ® Totables ® Irritation Relief Wipes Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days", "50567-7": "When using this product do not exceed the recommended daily dosage unless directed by a doctor", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.", "50569-3": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Astringent", "Purposes": "Protectant Vasoconstrictor", "Warnings": "For rectal 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 insertion of this product. detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows: hold suppository with rounded end up as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down" slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository remove exposed suppository from wrapper insert one suppository into the rectum 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", "Active ingredient": "Witch hazel 50.0%", "Other information": "store at 20-25°C (68-77°F)", "Active Ingredients": "Cocoa butter 88.44% Phenylephrine HCl 0.25%", "Inactive ingredients": "corn starch, methylparaben, propylparaben", "Questions or comments?": "Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374 For most recent product information, visit www.preparationh.com", "PRINCIPAL DISPLAY PANEL - Kit Carton": "SAME AMOUNT Smaller Package PREPARATION H ® HEMORRHOIDAL SUPPOSITORIES Provides Relief from MULTIPLE SYMPTOMS Reduces Internal Swelling, Soothes & Protects Prompt Soothing Relief from Painful Burning, Itching and Discomfort Also for Nighttime Relief + 4 FREE WIPES INSIDE 12 SUPPOSITORIES"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:55.843068 · Updated: 2026-03-14T23:02:45.179164