drug facts

drug facts

SPL v2

SPL

SPL Set ID 0f820ef2-88a1-4099-9b71-547bf0788269

Route

topical

Published

Effective Date 2009-11-19

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 1994-10-17

Purpose

Astringent

Description

Witch Hazel 50%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Avoid contact with eyes.

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.

Other Information

Store at room temperature 15° -30° C (59° - 86° F)

Inactive Ingredients

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

Description

Witch Hazel 50%

Use

For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids.

Do Not

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

Section 42229-5

Section 50567-7

Section 50568-5

Section 50569-3

Section 53413-1

Section 53414-9

Active Ingredient

Witch Hazel 50%

Package Information

Cat. No. 10-5400

NDC 50730-5400-0

Relief

Medicated hemorrhoidal towelettes

Comfort, soothe, cool - pH balanced

Triad Group, Inc.

700 West North Shore Drive

Hartland, WI 53029 USA

Made in USA

www.triad-group.net

100 Towelettes

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

For external use only.

Avoid contact with eyes.

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.

Other Information (Other information)

Store at room temperature 15° -30° C (59° - 86° F)

Inactive Ingredients

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

Use

For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids.

Do Not (Do not)

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

Section 42229-5 (42229-5)

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)

{"Use": "For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids.", "Do not": "put this product into the rectum using fingers or any mechanical device or applicator.", "Purpose": "Astringent", "Warnings": "For external use only. Avoid contact with eyes.", "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%", "Other information": "Store at room temperature 15° -30° C (59° - 86° F)", "Package Information": "Cat. No. 10-5400 NDC 50730-5400-0 Relief Medicated hemorrhoidal towelettes Comfort, soothe, cool - pH balanced Triad Group, Inc. 700 West North Shore Drive Hartland, WI 53029 USA Made in USA www.triad-group.net 100 Towelettes", "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

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Source: dailymed · Ingested: 2026-02-15T11:54:58.343083 · Updated: 2026-03-14T22:52:13.708968