84533-001 Hemorrhoid, Fissure, Proctalgia Suppositories

84533-001 Hemorrhoid, Fissure, Proctalgia Suppositories
SPL v4
SPL
SPL Set ID 1d40d16a-ee52-463a-e063-6394a90a6077
Route
TOPICAL
Published
Effective Date 2024-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Peppermint (0.2 g) Glycerin (8 g) Activated Charcoal (1 g) Sodium Sulfate Anhydrous (2 g) Borneol (3 g)
Inactive Ingredients
Polyethylene Glycol, Unspecified Polysorbate 60

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-17
Description

Carbon 1% Mirabilite 2% Peppermint oil 0.2% Borneol 3% Glycerin 8%

Medication Information

Warnings and Precautions

For external and/or intrarectal use.

Indications and Usage

temporarily protects the inflamed, irritatedanorectal surface to help make bowel movementsless painful from irritation and abrasion duringbowel movement

*provides temporary relief of pain, soreness, orburning*helps relieve the local or anorectal itching anddiscomfort associated with hemorrhoids

Dosage and Administration

adults and children 12 years of age and over:when practical, cleanse area with mild soap andwarm water and rinse thoroughly.Gently dry bypatting or blotting with toilet tissue or a soft clothbefore applying.Apply to the affected area up to 4 times daily,especially at night, in the morning or after eachbowel movement.For intrarectal use: after wetting, apply around theanal area and then insert into the rectum..children under 12 years of age: ask a doctor

Description

Carbon 1% Mirabilite 2% Peppermint oil 0.2% Borneol 3% Glycerin 8%

Section 44425-7

Additionalinformation:store in a cool, dry place.It is recommended tostore below 68°F(20°C)Refrigeration is advised.

Section 50565-1

Keep out of reach ofchildren.

lf swallowed, seek medicalhelp or contact a PolsonControl Center right away.

Section 51727-6

Polyethylene Glycol

POLYSORBATE 60

Section 51945-4

Section 55105-1

Adsorbent and detoxifying

Anti-inflammatory and soothing

Cooling and analgesic

Analgesic and anti-inflammatery

Humectant and moisturizing

Section 55106-9

Carbon 1%

Mirabilite 2%

Peppermint oil 0.2%

Borneol 3%

Glycerin 8%

Structured Label Content

Indications and Usage (34067-9)

temporarily protects the inflamed, irritatedanorectal surface to help make bowel movementsless painful from irritation and abrasion duringbowel movement

*provides temporary relief of pain, soreness, orburning*helps relieve the local or anorectal itching anddiscomfort associated with hemorrhoids

Dosage and Administration (34068-7)

adults and children 12 years of age and over:when practical, cleanse area with mild soap andwarm water and rinse thoroughly.Gently dry bypatting or blotting with toilet tissue or a soft clothbefore applying.Apply to the affected area up to 4 times daily,especially at night, in the morning or after eachbowel movement.For intrarectal use: after wetting, apply around theanal area and then insert into the rectum..children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

For external and/or intrarectal use.

Section 44425-7 (44425-7)

Additionalinformation:store in a cool, dry place.It is recommended tostore below 68°F(20°C)Refrigeration is advised.

Section 50565-1 (50565-1)

Keep out of reach ofchildren.

lf swallowed, seek medicalhelp or contact a PolsonControl Center right away.

Section 51727-6 (51727-6)

Polyethylene Glycol

POLYSORBATE 60

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Adsorbent and detoxifying

Anti-inflammatory and soothing

Cooling and analgesic

Analgesic and anti-inflammatery

Humectant and moisturizing

Section 55106-9 (55106-9)

Carbon 1%

Mirabilite 2%

Peppermint oil 0.2%

Borneol 3%

Glycerin 8%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.705845 · Updated: 2026-03-14T23:12:24.385926