SPL v4
SPL
SPL Set ID 29a433bc-a833-ffc7-e063-6294a90a465a
Route
TOPICAL
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (0.5 mg)
Inactive Ingredients
Decyl Glucoside Sodium Benzoate Potassium Sorbate Water Phenoxyethanol Aloe Barbadensis Leaf Citric Acid Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-15

Description

Witch Hazel 50%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

* Help relieve pain and swelling from hemorrhoids and childbirth

* Temporary relief from: irritation, burning, discomfort

Dosage and Administration

* Remove one liner from the pack and reseal the lid.

* Place the liner on top of a maxi pad.

* Close lid after use to retain moisture.

* Replace Pad liner with each maxi pad change

Description

Witch Hazel 50%

Section 44425-7

* Store at room temperature

* Single use per wipe

* Close lid after every use to retain moisture

* Discard after every use

* Not flushable

Section 50565-1

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

Section 50566-9

Stop use and ask and ask a dotor if

* Rectal bleeding occurs.

* Condition worsens or does not improve within 7 days.

Section 50567-7

When using this product:

* Avoid contact with eyes. If contact occurs, rinse thorougly with water.

* Do not exceed the recommended daily dosage unless directed by doctor.

* Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Section 51727-6

Water, aloe barbadensis leaf extract,, citric acid, decyl glucoside, glycerin, potassium sorbate, sodium benzoate, phenoxyethanol

Section 51945-4

Section 55105-1

* Help relieve pain and swelling from hemorrhoids and childbirth

* Temporary relief from: irritation, burning, discomfort

Section 55106-9

Witch Hazel 50%


Structured Label Content

Indications and Usage (34067-9)

* Help relieve pain and swelling from hemorrhoids and childbirth

* Temporary relief from: irritation, burning, discomfort

Dosage and Administration (34068-7)

* Remove one liner from the pack and reseal the lid.

* Place the liner on top of a maxi pad.

* Close lid after use to retain moisture.

* Replace Pad liner with each maxi pad change

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

* Store at room temperature

* Single use per wipe

* Close lid after every use to retain moisture

* Discard after every use

* Not flushable

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask and ask a dotor if

* Rectal bleeding occurs.

* Condition worsens or does not improve within 7 days.

Section 50567-7 (50567-7)

When using this product:

* Avoid contact with eyes. If contact occurs, rinse thorougly with water.

* Do not exceed the recommended daily dosage unless directed by doctor.

* Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Section 51727-6 (51727-6)

Water, aloe barbadensis leaf extract,, citric acid, decyl glucoside, glycerin, potassium sorbate, sodium benzoate, phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

* Help relieve pain and swelling from hemorrhoids and childbirth

* Temporary relief from: irritation, burning, discomfort

Section 55106-9 (55106-9)

Witch Hazel 50%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)