47ba86ad-240a-e733-e063-6394a90a24e3

SPL v2
SPL
SPL Set ID 47ba86ad-240a-e733-e063-6394a90a24e3
Route
rectal
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
witch hazel (3.75 g) glycerin (3 g) menthol (0.075 g)
Inactive Ingredients
ethylparaben epidihydrocholesterin limonene, (+)- aloe vera leaf polysaccharides menthol propylene glycol carbonate, (-)- aloe emodin citric acid monohydrate vitamin a vitamin k-dependent protein c 4'-demethylepipodofilox benzylidene glycoside glucomannan vitamin e polyethylene glycol succinate mineral oil carbomer isoglycyrrhizinic acid mimosine colchicine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-02-01
Description

cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth for application in the lower anal canal: remove cover from dispensing cap, attach dispensing cap to tube, lubricate well, then gently insert dispensing cap partway into the anus thoroughly cleanse dispensing cap after each use and replace cover children under 12 years of age consult your pediatrician adults: apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Medication Information

Warnings and Precautions
  • for external use only
  • when using finger cots or an applicator, apply externally or to the skin of the anal canal only
  • do not put this product into the rectum
Active Ingredient

Witch Hazel (25%) ……… Astringent

Menthol (0.5%) …………. Analgesic

Glycerin (20%) …………… Protectant

Indications and Usage
  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves pain, soreness, or burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Dosage and Administration
  • cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth
  • for application in the lower anal canal: remove cover from dispensing cap, attach dispensing cap to tube, lubricate well, then gently insert dispensing cap partway into the anus
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age consult your pediatrician
  • adults: apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
Description

cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth for application in the lower anal canal: remove cover from dispensing cap, attach dispensing cap to tube, lubricate well, then gently insert dispensing cap partway into the anus thoroughly cleanse dispensing cap after each use and replace cover children under 12 years of age consult your pediatrician adults: apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

* bleeding occurs

* an allergic reaction develops

* condition worsens or does not improve within seven days

* the symptom being treated does not subside or if redness, iritation, swelling, pain or other symptoms develop or increase

Section 50568-5

Ask a doctor/pharmacist before use if you are

* presently taking a prescription drug for high blood pressure or depression

* pregnant or breast-feeding

Section 50569-3

Ask a doctor before use if you have

* heart disease * diabetes

* thyroid disease * high blood pressure

* difficulty in urination due to enlargement of the prostate gland

* allergies to any of the components of this product

Section 51727-6

Vitamin A、 C、E, Citric Acid Monohydrate, Isoglycyrrhizinic acid, Mimosine, Epidihydrocholesterin, Colchicine, Mineral Oil, Glucomannan, Aloe-emodin, 4'-Demethylepipodofilox Benzylidene Glycoside, Aloe Vera Leaf Polysaccharides, Limonene, Carbomer, Menthol Propylene Glycol Carbonate, Ethylparaben

Section 51945-4

Section 53413-1

Questions or comments?

Email: [email protected]

Section 55105-1
  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves pain, soreness, or burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Structured Label Content

Warnings and Precautions (34071-1)
  • for external use only
  • when using finger cots or an applicator, apply externally or to the skin of the anal canal only
  • do not put this product into the rectum
Active Ingredient (55106-9)

Witch Hazel (25%) ……… Astringent

Menthol (0.5%) …………. Analgesic

Glycerin (20%) …………… Protectant

Indications and Usage (34067-9)
  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves pain, soreness, or burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Dosage and Administration (34068-7)
  • cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth
  • for application in the lower anal canal: remove cover from dispensing cap, attach dispensing cap to tube, lubricate well, then gently insert dispensing cap partway into the anus
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age consult your pediatrician
  • adults: apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

* bleeding occurs

* an allergic reaction develops

* condition worsens or does not improve within seven days

* the symptom being treated does not subside or if redness, iritation, swelling, pain or other symptoms develop or increase

Section 50568-5 (50568-5)

Ask a doctor/pharmacist before use if you are

* presently taking a prescription drug for high blood pressure or depression

* pregnant or breast-feeding

Section 50569-3 (50569-3)

Ask a doctor before use if you have

* heart disease * diabetes

* thyroid disease * high blood pressure

* difficulty in urination due to enlargement of the prostate gland

* allergies to any of the components of this product

Section 51727-6 (51727-6)

Vitamin A、 C、E, Citric Acid Monohydrate, Isoglycyrrhizinic acid, Mimosine, Epidihydrocholesterin, Colchicine, Mineral Oil, Glucomannan, Aloe-emodin, 4'-Demethylepipodofilox Benzylidene Glycoside, Aloe Vera Leaf Polysaccharides, Limonene, Carbomer, Menthol Propylene Glycol Carbonate, Ethylparaben

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Email: [email protected]

Section 55105-1 (55105-1)
  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves pain, soreness, or burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.099763 · Updated: 2026-03-14T23:13:40.815212