drug facts

drug facts

SPL v1

SPL

SPL Set ID 58c232b8-0793-4079-baee-22479a8ed3b9

Routes

rectal topical

Published

Effective Date 2009-11-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

witch hazel (.5 mL)

Inactive Ingredients

citric acid monohydrate diazolidinylurea glycerin methylparaben propylene glycol propylparaben sodium citrate water

Identifiers & Packaging

Marketing Status

otc monograph final active Since 1997-01-14

Purpose

Astringent

Description

Witch Hazel 50%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Uses

Temporarily relieves these symptoms associated with hemorrhoids:

itching
burning
irritation

Purpose

Astringent

Directions

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. Gently apply to the affected area by patting and then discard. Apply to the affected area up to 6 times daily or after each bowel movement.
Children under 12 years of age: consult a doctor.

Inactive Ingredients

citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Description

Witch Hazel 50%

Do Not

put this product into rectum using fingers or any mechanical device or applicator

Section 42229-5

Section 44425-7

Section 50567-7

Section 50568-5

Section 50569-3

Section 53413-1

Section 53414-9

Active Ingredient

Witch Hazel 50%

Package Information

CAT. NO. 10-7540

NDC 50730-7502-1

Relief

Pre-Moistened

Hemorrhoidal Pads

Comforts - Cools - Soothes

Compares to the leading brand

40 PADS

Triad Disposables, Inc.

Brookfield, WI 53045

Made In USA

Stop Use and Ask A Doctor

if condition worsens or does not improve within 7 days
in case of bleeding
before exceeding the recommended dosage

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings (WARNINGS)

For external use only.

Uses (USES)

Temporarily relieves these symptoms associated with hemorrhoids:

itching
burning
irritation

Purpose (PURPOSE)

Astringent

Directions (DIRECTIONS)

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. Gently apply to the affected area by patting and then discard. Apply to the affected area up to 6 times daily or after each bowel movement.
Children under 12 years of age: consult a doctor.

Inactive Ingredients (Inactive ingredients)

citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Do Not (Do not)

put this product into rectum using fingers or any mechanical device or applicator

Section 42229-5 (42229-5)

Section 44425-7 (44425-7)

Section 50567-7 (50567-7)

Section 50568-5 (50568-5)

Section 50569-3 (50569-3)

Section 53413-1 (53413-1)

Section 53414-9 (53414-9)

Active Ingredient (ACTIVE INGREDIENT)

Witch Hazel 50%

Package Information

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

if condition worsens or does not improve within 7 days
in case of bleeding
before exceeding the recommended dosage

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.

Advanced Ingredient Data

[{"name": "witch hazel", "unii": "101I4J0U34", "classCode": "ACTIB", "strengthNumerator": ".5", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "1"}, {"name": "citric acid monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "diazolidinylurea", "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", "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": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "Temporarily relieves these symptoms associated with hemorrhoids: itching burning irritation", "Do not": "put this product into rectum using fingers or any mechanical device or applicator", "PURPOSE": "Astringent", "WARNINGS": "For external use only.", "DIRECTIONS": "When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. Gently apply to the affected area by patting and then discard. Apply to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.", "ACTIVE INGREDIENT": "Witch Hazel 50%", "Package Information": "CAT. NO. 10-7540 NDC 50730-7502-1 Relief Pre-Moistened Hemorrhoidal Pads Comforts - Cools - Soothes Compares to the leading brand 40 PADS Triad Disposables, Inc. Brookfield, WI 53045 Made In USA", "Inactive ingredients": "citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water", "Stop use and ask a doctor": "if condition worsens or does not improve within 7 days in case of bleeding before exceeding the recommended dosage", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:54:58.282569 · Updated: 2026-03-14T22:52:13.708968