SPL v2
SPL
SPL Set ID 227a452f-458f-cf5f-e063-6394a90af92d
Route
TOPICAL
Published
Effective Date 2024-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (500 mg)
Inactive Ingredients
Phenoxyethanol Potassium Sorbate Edetate Disodium Water Ethylhexylglycerin Glycerin Sodium Citrate, Unspecified Form Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-30

Description

Witch hazel

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch hazel

Uses

temporarily relieves the local itching and discomfort associated with hemorrhoids

aids in protecting irritated ahorectal areas

temporarily relieves irritation and burning

Label

Directions

Adults:

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

Children under 12 years of age: ask a doctor

Active Ingredient

Witch hazel

Other Information

DO NOT FLUSH-after application, discard pad in trash and wash hands

for use as a moist compress -- if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat asbut not to exceed directions for use

Inactive Ingredients

Water

Glycerin

Sodium Citrate, Unspecified form

Citric Acid Monohydrate

Ethylhexylglycerin

Phenoxyethanol

Edetate Disodium

Potassium Sorbate

When Using This Product

do not use more than directed unless told to do so by a doctor

do not put directly in the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask Doctor If

rectal bleeding occurs

condition worsens or does not improve within 7 days

Keep Out of the Reach of Children

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


Structured Label Content

Uses

temporarily relieves the local itching and discomfort associated with hemorrhoids

aids in protecting irritated ahorectal areas

temporarily relieves irritation and burning

Label (label)

Purpose

Astringent

Directions

Adults:

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

Children under 12 years of age: ask a doctor

Active Ingredient (Active ingredient)

Witch hazel

Other Information (Other information)

DO NOT FLUSH-after application, discard pad in trash and wash hands

for use as a moist compress -- if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat asbut not to exceed directions for use

Inactive Ingredients (Inactive ingredients)

Water

Glycerin

Sodium Citrate, Unspecified form

Citric Acid Monohydrate

Ethylhexylglycerin

Phenoxyethanol

Edetate Disodium

Potassium Sorbate

When Using This Product (When using this product)

do not use more than directed unless told to do so by a doctor

do not put directly in the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask Doctor If (Stop use and ask doctor if)

rectal bleeding occurs

condition worsens or does not improve within 7 days

Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

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