SPL v1
SPL
SPL Set ID 325b2637-ec39-fc14-e063-6394a90a1e23
Route
TOPICAL
Published
Effective Date 2025-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (20 mg) Mint (8 mg) Aloe (10 mg) Pleione Yunnanensis Whole
Inactive Ingredients
Xanthan Gum Mimosine Menthol Citric Acid Rebaudioside A Cholesteryl Nonanoate Glucomannan Vitamin E Polyethylene Glycol Succinate Ascorbic Acid Vitamin A Colchicine Aloe Emodin Water Pinitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-09

Description

Witch Hazel, Pleione, Aloe, Mint


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

0pen the lid on the top of the wipes pouch

Peel back wipes seal, remove completely and discard

Grab the top wipe at the edge of the center fold and pull out of pouch

Close lid after each use to retain moisture

Adults: Unfold wipe and cleanse the area by gently wiping, pating or blotting. lf necessary, repeat until all matter is removed

from the area.Use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments and then discardChildren under 12 years of age: consult a doctor

Dosage and Administration

Adults: Unfold wipe and cleanse the area by gently wiping, pating or blotting. lf necessary, repeat unti all matter is removed

from the area.

I Use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments and then discard

Description

Witch Hazel, Pleione, Aloe, Mint

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help or contact a poisen control center right away.

Section 50566-9

Bleeding occurs

Condition worsens or does not improve within 7 days

Section 50567-7

When Using this product

Do not exceed the recommended daily dosage unless directed by a doctorDo not put this product into the rectum by using fingers or any mechanical device or applicator

Section 51727-6

Vitamin A

Vitamin C

Vitamin E

Glycyrrhizic acid

Mimosine

D-Pinitol

Colchicine

Aloe-emodin glycoside

Polysaccharide

Citric acid

Glycoside

Cholesterin

Menthol

Glucomannan

Purified water

Section 51945-4

Section 55105-1

EVERYDAY CLEANSING & SOOTHINGI SAFE FOR INTIMATE USE

Section 55106-9

Witch Hazel, Pleione, Aloe, Mint


Structured Label Content

Indications and Usage (34067-9)

0pen the lid on the top of the wipes pouch

Peel back wipes seal, remove completely and discard

Grab the top wipe at the edge of the center fold and pull out of pouch

Close lid after each use to retain moisture

Adults: Unfold wipe and cleanse the area by gently wiping, pating or blotting. lf necessary, repeat until all matter is removed

from the area.Use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments and then discardChildren under 12 years of age: consult a doctor

Dosage and Administration (34068-7)

Adults: Unfold wipe and cleanse the area by gently wiping, pating or blotting. lf necessary, repeat unti all matter is removed

from the area.

I Use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments and then discard

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help or contact a poisen control center right away.

Section 50566-9 (50566-9)

Bleeding occurs

Condition worsens or does not improve within 7 days

Section 50567-7 (50567-7)

When Using this product

Do not exceed the recommended daily dosage unless directed by a doctorDo not put this product into the rectum by using fingers or any mechanical device or applicator

Section 51727-6 (51727-6)

Vitamin A

Vitamin C

Vitamin E

Glycyrrhizic acid

Mimosine

D-Pinitol

Colchicine

Aloe-emodin glycoside

Polysaccharide

Citric acid

Glycoside

Cholesterin

Menthol

Glucomannan

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

EVERYDAY CLEANSING & SOOTHINGI SAFE FOR INTIMATE USE

Section 55106-9 (55106-9)

Witch Hazel, Pleione, Aloe, Mint


Advanced Ingredient Data


Raw Label Data

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