SPL v2
SPL
SPL Set ID 236e8d8e-e633-0efd-e063-6394a90a08b4
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
Glycerin Ethylhexylglycerin Water Sodium Citrate, Unspecified Form Citric Acid Monohydrate Phenoxyethanol Edetate Disodium Potassium Sorbate

Identifiers & Packaging

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

Description

Witch hazel (50% w/w)

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch hazel (50% w/w)

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 fot 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 (50% w/w)

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 the wipe in contact with the irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use

Inactive Ingredients

Water

Glycerin

Sodium Citrate, Unspecified form

Citric Acid Monohydrate

Ethylhexylglycerin

Phenoxyethanol

Edetate Disodium

Potassium Sorbate

Stop Use and Ask A 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 call 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 fot 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 (50% w/w)

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 the wipe in contact with the irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but 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

Stop Use and Ask A Doctor If (Stop use and ask a 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 call a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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