84533-003 Hemorrhoid, Fissure, Proctalgia Ointment

84533-003 Hemorrhoid, Fissure, Proctalgia Ointment
SPL v4
SPL
SPL Set ID 1efe43d5-a29b-5cb2-e063-6394a90aca66
Route
TOPICAL
Published
Effective Date 2024-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Sulfate Anhydrous (2 g) Borneol (3 g) Activated Charcoal (1 g) Peppermint (0.2 g) Glycerin (8 g)
Inactive Ingredients
Peg-23 Stearate Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-06

Description

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


Medication Information

Warnings and Precautions

For eoternat and/or intrarectal use.

Indications and Usage

instantly heips relieve anorectai itching and discomfort such as pain, sore-ness or burning commonlyassociated with hemorhoids.

tomporarily protects the inflamed, irritated anorectal area to make futurebowei mowements less painfut from irritation and abrasion.

Dosage and Administration

.aduits and chlkdren 12 years of oage and oer when practical,cleanse area with mild soap and warm water and rinsethorcughiy, Gently dry by patting or blotting with tollet tissue ora sodt cloth before applying.Apply to the atfected area up to 4 times daily, cspecially atnight, in the moming or after each bowei movement.For intrarectaluse: after watting, apply around the anad creaand then insert tip into tho reatum, then use provided oowerpads.

. children under 12 yoars cf age ask a doctor

Description

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

Section 50565-1

Keep out of reaah of children.

if swallowed, seek medical help or contact a poison control center right away.

Section 51727-6

Polyethylene Glycol

Polyoxyethylene (40) Stearate

Section 51945-4

Section 55105-1

Adsorbent and detoxifying

Anti-infmmatoty and soothing

cooling and analgesic

Analgesic and anti-infiommatoey

Humectant and moistueizing

Section 55106-9

Carbon 1%

Mirabilite 2%

Peppermint oil 0.2%

Borneol 3%

Glycerin 8%


Structured Label Content

Indications and Usage (34067-9)

instantly heips relieve anorectai itching and discomfort such as pain, sore-ness or burning commonlyassociated with hemorhoids.

tomporarily protects the inflamed, irritated anorectal area to make futurebowei mowements less painfut from irritation and abrasion.

Dosage and Administration (34068-7)

.aduits and chlkdren 12 years of oage and oer when practical,cleanse area with mild soap and warm water and rinsethorcughiy, Gently dry by patting or blotting with tollet tissue ora sodt cloth before applying.Apply to the atfected area up to 4 times daily, cspecially atnight, in the moming or after each bowei movement.For intrarectaluse: after watting, apply around the anad creaand then insert tip into tho reatum, then use provided oowerpads.

. children under 12 yoars cf age ask a doctor

Warnings and Precautions (34071-1)

For eoternat and/or intrarectal use.

Section 50565-1 (50565-1)

Keep out of reaah of children.

if swallowed, seek medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Polyethylene Glycol

Polyoxyethylene (40) Stearate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Adsorbent and detoxifying

Anti-infmmatoty and soothing

cooling and analgesic

Analgesic and anti-infiommatoey

Humectant and moistueizing

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)