SPL v1
SPL
SPL Set ID 1ddb794f-6c02-6ffa-e063-6394a90a9318
Route
TOPICAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (50 g)
Inactive Ingredients
Citric Acid Monohydrate Water Tocopherol Polyoxyl 40 Hydrogenated Castor Oil Stephania Tetrandra Root Phenoxyethanol Mentha Canadensis Whole Cocamidopropyl Betaine Hydroxyacetophenone Saururus Chinensis Whole Lauryl Glucoside Sodium Lauroyl Glutamate Erythritol Alcohol Taraxacum Officinale 1,2-hexanediol Butylene Glycol Sodium Lauroyl Sarcosinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01
Description

• Cleanse the affected area by using a peri bottle or mild soap and warm water. Gently dry by patting or blotting with toilet tissue or soft, clean cloth. • Add foam to the top of each new absorbant pad or pad liner for healing relief. • Apply to the affected area up to 6 times daily or after each bowel movement. • Children under 12 years of age, consult a doctor before use.

Medication Information

Warnings and Precautions

For external use only

When using this product • Avoid eye contact with eyes. If contact occurs, rinse

thoroughly with water. • Do not exceed the recommended daily dosage unless

directed by a doctor. • Do not put this product into the rectum by using finger or

any mechanical device or applicator.

Indications and Usage

Helps relieve pain and swelling from hemorrhoids and childbirth.

Description

• Cleanse the affected area by using a peri bottle or mild soap and warm water. Gently dry by patting or blotting with toilet tissue or soft, clean cloth. • Add foam to the top of each new absorbant pad or pad liner for healing relief. • Apply to the affected area up to 6 times daily or after each bowel movement. • Children under 12 years of age, consult a doctor before use.

Section 50565-1

If swallowed, get medical help or contact a Poison

Control Center right away. (1-800-222-1222)

Section 50569-3

Stop use and ask a doctor if • Rectal bleeding occurs.

• Condition worsens or does not improve within 7 days.

Section 51727-6

1,2-Hexanediol, Alcohol, Butylene Glycol, C12-18 Alkyl

Glucoside, Citric Acid, Cocamidopropyl Betain, Erythritol, Fragrance (Parfum),

Hamamelis virginiana, Hydroxyacetophenone, Mentha Haplocalyx Oil,

Phenoxyethanol, Polyoxyl 40 Hydrogenated Castor Oil, Saururus Chinensis

Leaf/Root Extract, Sodium Lauroyl Glutamate, Sodium Lauroyl Sarcosinate,

Stephania Tetrandra Extract, Taraxacum Officinale (Dandelion) Leaf Extract,

Tocopherol, Water

Section 51945-4

Section 55105-1

Astringent

Section 55106-9

Witch Hazel 50%

Section 60561-8

• Store at room temperature • Single use per wipe

Directions

• Cleanse the affected area by using a peri bottle or mild soap and

warm water. Gently dry by patting or blotting with toilet tissue or soft, clean cloth.

• Add foam to the top of each new absorbant pad or pad liner for healing relief.

• Apply to the affected area up to 6 times daily or after each bowel movement.

• Children under 12 years of age, consult a doctor before use.

Structured Label Content

Indications and Usage (34067-9)

Helps relieve pain and swelling from hemorrhoids and childbirth.

Warnings and Precautions (34071-1)

For external use only

When using this product • Avoid eye contact with eyes. If contact occurs, rinse

thoroughly with water. • Do not exceed the recommended daily dosage unless

directed by a doctor. • Do not put this product into the rectum by using finger or

any mechanical device or applicator.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison

Control Center right away. (1-800-222-1222)

Section 50569-3 (50569-3)

Stop use and ask a doctor if • Rectal bleeding occurs.

• Condition worsens or does not improve within 7 days.

Section 51727-6 (51727-6)

1,2-Hexanediol, Alcohol, Butylene Glycol, C12-18 Alkyl

Glucoside, Citric Acid, Cocamidopropyl Betain, Erythritol, Fragrance (Parfum),

Hamamelis virginiana, Hydroxyacetophenone, Mentha Haplocalyx Oil,

Phenoxyethanol, Polyoxyl 40 Hydrogenated Castor Oil, Saururus Chinensis

Leaf/Root Extract, Sodium Lauroyl Glutamate, Sodium Lauroyl Sarcosinate,

Stephania Tetrandra Extract, Taraxacum Officinale (Dandelion) Leaf Extract,

Tocopherol, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Astringent

Section 55106-9 (55106-9)

Witch Hazel 50%

Section 60561-8 (60561-8)

• Store at room temperature • Single use per wipe

Directions

• Cleanse the affected area by using a peri bottle or mild soap and

warm water. Gently dry by patting or blotting with toilet tissue or soft, clean cloth.

• Add foam to the top of each new absorbant pad or pad liner for healing relief.

• Apply to the affected area up to 6 times daily or after each bowel movement.

• Children under 12 years of age, consult a doctor before use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:09.580369 · Updated: 2026-03-14T23:04:39.787858