Hemrrhoidal Hygiene Pads

Hemrrhoidal Hygiene Pads
SPL v4
SPL
SPL Set ID e04a9fbf-69c0-469e-9d07-30711c3d6bf6
Route
RECTAL
Published
Effective Date 2018-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (50 g)
Inactive Ingredients
Alcohol Acetyltributyl Citrate Water Glycerin Sodium Citrate Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-31

Description

Witch Hazel 50% Purpose: Hemorrhoidal Astringent


Medication Information

Warnings and Precautions

• For External Use Only

•Avoid contact with the eyes

Consult a doctor

• If condition worsens or does not improve within 7 days

• In case of bleeding

• Before exceeding the recommended dosage

DO NOT put this product into the rectum

using fingers or any mechanical device.

Dosage and Administration

Apply externally to the affected area up to

6 times daily or after each bowel movement

Description

Witch Hazel 50% Purpose: Hemorrhoidal Astringent

Uses

For temporary relief of local discomfort,

burning and irritation associated with Hemorrhoids

Section 44425-7

Store at room temperature 15°-30°C

(59°-86°F)

Section 50565-1

If swallowed, contact the Poison Control Center immediately.

Section 51945-4

Directions

When practical, clean the affected area

with mild soap and warm water, and rinse

thoroughly

• Gently dry by patting or blotting with

toilet tissue or a soft cloth before applying

• Apply externally to the affected area up to

6 times daily or after each bowel movement

• After application, discard pad

Children under 12 years of age: consult a

doctor

Drug Facts

Witch Hazel 50%

Purpose: Hemorrhoidal Astringent

Other Ingredient

Alcohol, Citric Acid,

Deionized Water, DMDM Hydantoin,

Glycerin, Sodium Citrate.


Structured Label Content

Uses

For temporary relief of local discomfort,

burning and irritation associated with Hemorrhoids

Dosage and Administration (34068-7)

Apply externally to the affected area up to

6 times daily or after each bowel movement

Warnings and Precautions (34071-1)

• For External Use Only

•Avoid contact with the eyes

Consult a doctor

• If condition worsens or does not improve within 7 days

• In case of bleeding

• Before exceeding the recommended dosage

DO NOT put this product into the rectum

using fingers or any mechanical device.

Section 44425-7 (44425-7)

Store at room temperature 15°-30°C

(59°-86°F)

Section 50565-1 (50565-1)

If swallowed, contact the Poison Control Center immediately.

Section 51945-4 (51945-4)

Directions

When practical, clean the affected area

with mild soap and warm water, and rinse

thoroughly

• Gently dry by patting or blotting with

toilet tissue or a soft cloth before applying

• Apply externally to the affected area up to

6 times daily or after each bowel movement

• After application, discard pad

Children under 12 years of age: consult a

doctor

Drug Facts

Witch Hazel 50%

Purpose: Hemorrhoidal Astringent

Other Ingredient

Alcohol, Citric Acid,

Deionized Water, DMDM Hydantoin,

Glycerin, Sodium Citrate.


Advanced Ingredient Data


Raw Label Data

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