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SPL v1

SPL

SPL Set ID 8a885822-42e7-44e0-82d6-fa967123866e

Route

RECTAL

Published

Effective Date 2018-05-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cocoa Butter (88.5 g) Phenylephrine (0.26 g)

Inactive Ingredients

Methylparaben Propylparaben Modified Corn Starch (1-octenyl Succinic Anhydride)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-03-25

Description

Active Ingredients Purpose Cocoa butter 88.50%...................................................................Protectant Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

Purpose

Protectant Vasoconstrictor

Medication Information

Purpose

Protectant

Vasoconstrictor

Description

Uses

temporarily shrinks hemorrhoidal tissue
temporarily relieves itching, burning, and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas

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 toilet tissue or a soft cloth.

-remove the wrapper before inserting into the rectum.

-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: consult a doctor

Carton Label

Other Information

Store at 20-25^oC (68-77^oF)

Active Ingredients

Active Ingredients Purpose

Cocoa butter 88.50%...................................................................Protectant

Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

Inactive Ingredients

corn starch, methylparaben, propylparaben

When Using This Product

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

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If

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

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

-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

Structured Label Content

Uses

temporarily shrinks hemorrhoidal tissue
temporarily relieves itching, burning, and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas

Purpose

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 toilet tissue or a soft cloth.

-remove the wrapper before inserting into the rectum.

-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: consult a doctor

Carton Label

Other Information (Other information)

Store at 20-25^oC (68-77^oF)

Active Ingredients (Active ingredients)

Active Ingredients Purpose

Cocoa butter 88.50%...................................................................Protectant

Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

Inactive Ingredients (Inactive ingredients)

corn starch, methylparaben, propylparaben

When Using This Product (When using this product)

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

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 or condition worsens or does not improve within 7 days

Keep Out of Reach of Children (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)

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": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "ACTIB", "strengthNumerator": "88.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "0.26", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "0.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "0.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)", "unii": "461P5CJN6T", "classCode": "IACT", "strengthNumerator": "11.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily shrinks hemorrhoidal tissue temporarily relieves itching, burning, and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas", "Purpose": "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 toilet tissue or a soft cloth. -remove the wrapper before inserting into the rectum. -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: consult a doctor", "Other information": "Store at 20-25 o C (68-77 o F)", "Active ingredients": "Active Ingredients Purpose Cocoa butter 88.50%...................................................................Protectant Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor", "Inactive ingredients": "corn starch, methylparaben, propylparaben", "When using this product": "do not exceed the recommended daily dosage unless directed by a doctor", "If pregnant or breastfeeding": "ask a health professional before use.", "Stop use and ask a doctor if": "bleeding occurs or condition worsens or does not improve within 7 days", "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": "-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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:33.740956 · Updated: 2026-03-14T22:55:06.338046