HEMORRHOID, FISSURE, PROCTALGIASUPPOSITORIES- carbon, mirabilite, peppermint oil, borneol suppository

Hemorrhoid, Fissure, ProctalgiaSuppositories by

Drug Labeling and Warnings

Hemorrhoid, Fissure, ProctalgiaSuppositories by is a Otc medication manufactured, distributed, or labeled by WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Glycerin 8%

PURPOSE

Adsorbent and detoxifying
Anti-inflammatory and soothing
Cooling and analgesic
Analgesic and anti-inflammatery
Humectant and moisturizing

KEEP OUT OF REACH OF CHILDREN

Keep out of reach ofchildren.
lf swallowed, seek medicalhelp or contact a PolsonControl Center right away.

INDICATIONS & 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

WARNINGS

For external and/or intrarectal use.

DOSAGE & 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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Polyethylene Glycol
POLYSORBATE 60

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOID, FISSURE, PROCTALGIASUPPOSITORIES 
carbon, mirabilite, peppermint oil, borneol suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84533-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	0.2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	8 g  in 100 g
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	1 g  in 100 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	2 g  in 100 g
BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X)	BORNEOL	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84533-001-01	7 g in 1 BOX; Type 0: Not a Combination Product	07/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	07/17/2024

Labeler - WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. (412779339)

Establishment
Name	Address	ID/FEI	Business Operations
WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.		412779339	manufacture(84533-001)