Pranicura 5

Pranicura 5
SPL v5
SPL
SPL Set ID af520a58-3f3c-4d28-a41f-3ed8f74da095
Route
TOPICAL
Published
Effective Date 2024-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (25.0 g) Kaolin (12.5 g) Zinc Cation (1.0 g) Menthol
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cetostearyl Alcohol Water Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Isopropyl Palmitate Magnesium Aluminum Silicate Phenoxyethanol Polysorbate 20 Propylene Glycol Alcohol Silicon Dioxide Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-18

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For rectal use only

Do not use unless a prior doctor’s diagnosis of anorectal condition has been made

When using this product do not exceed the recommended daily dosage unless

directed by a doctor

Stop use and ask a doctor if • bleeding occurs • condition worsens or does not

improve within 7 days • allergic reaction develops • symptoms being treated do not

subside or if redness, irritation, swelling, pain, other symptoms develop or increase

• Do not put this product into the rectum by using fingers or any mechanical device or

applicator.

• Remove petrolatum or greasy ointment before using this product because they

interfere with the ability of this product to adhere properly to the skin area

If pregnant or breastfeeding, ask a health professional before use

Indications and Usage

Uses • Helps relieve the itching and discomfort associated with anorectal disorders •

Provides temporary relief from the symptoms of perianal skin irritation • For the temporary

relief of itching associated with moist anorectal conditions • For the temporary relief of

irritation and burning

Dosage and Administration

Other Information store at 15-30º C (59-86º F)

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away

Section 51727-6

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,

Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium

Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol,

Silica, Stearyl Alcohol

Section 51945-4

PRANICURA 5

​Ultimate Relief from Pruritus Ani, Fissures and Hemmorhoids

Available only at: www.pranicura.com

Net Wt. 2.1 oz. (60 g)

RES

Section 53413-1

Questions or Comments? Call weekdays 9 AM to 5 PM CST at 763-537-3419

Section 55105-1

Purposes

Glycerin ....................................................Protectant

Kaolin .........................................Protectant/Anti-Itch

Calamine ....................................Protectant/Anti-Itch

Menthol .....................................................Analgesic

Section 55106-9

Active Ingredients

Glycerin      25%

Kaolin        12.5%

Calamine   12.5%

Menthol        1%

Section 60561-8

Other Information store at 15-30º C (59-86º F)


Structured Label Content

Indications and Usage (34067-9)

Uses • Helps relieve the itching and discomfort associated with anorectal disorders •

Provides temporary relief from the symptoms of perianal skin irritation • For the temporary

relief of itching associated with moist anorectal conditions • For the temporary relief of

irritation and burning

Dosage and Administration (34068-7)

Other Information store at 15-30º C (59-86º F)

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Do not use unless a prior doctor’s diagnosis of anorectal condition has been made

When using this product do not exceed the recommended daily dosage unless

directed by a doctor

Stop use and ask a doctor if • bleeding occurs • condition worsens or does not

improve within 7 days • allergic reaction develops • symptoms being treated do not

subside or if redness, irritation, swelling, pain, other symptoms develop or increase

• Do not put this product into the rectum by using fingers or any mechanical device or

applicator.

• Remove petrolatum or greasy ointment before using this product because they

interfere with the ability of this product to adhere properly to the skin area

If pregnant or breastfeeding, ask a health professional before use

Section 42229-5 (42229-5)

Drug Facts

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 51727-6 (51727-6)

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,

Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium

Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol,

Silica, Stearyl Alcohol

Section 51945-4 (51945-4)

PRANICURA 5

​Ultimate Relief from Pruritus Ani, Fissures and Hemmorhoids

Available only at: www.pranicura.com

Net Wt. 2.1 oz. (60 g)

RES

Section 53413-1 (53413-1)

Questions or Comments? Call weekdays 9 AM to 5 PM CST at 763-537-3419

Section 55105-1 (55105-1)

Purposes

Glycerin ....................................................Protectant

Kaolin .........................................Protectant/Anti-Itch

Calamine ....................................Protectant/Anti-Itch

Menthol .....................................................Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Glycerin      25%

Kaolin        12.5%

Calamine   12.5%

Menthol        1%

Section 60561-8 (60561-8)

Other Information store at 15-30º C (59-86º F)


Advanced Ingredient Data


Raw Label Data

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