Pranicura

Manufacturer
Pranicura, LLC | Sarati International, Inc.
Effective date
2020-12-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:02:40

Label at a glance#

ProductPranicura
Active ingredientGLYCERIN, KAOLIN, ZINC OXIDE, MENTHOL
Label structure14 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Glycerin 25%
Kaolin 12.5%
Calamine 12.5%
Menthol 1%

OTC - PURPOSE SECTION

Purposes

Glycerin ..........Protectant
Kaolin .............Protectant/Anti-Itch
Calamine .........Protectant/Anti-Itch
Menthol ...........Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
For rectal use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product do not exceed the recommended daily dosage unless
directed by a doctor

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions
• Adults: When practical, cleanse the affected area by patting or blotting with an
appropriate cleansing wipe. Gently dry by patting or blotting with toilet tissue or a soft
cloth before application of this product.
• For Pruritus Ani: Wait 20 seconds after drying. If the desire to scratch is gone, do not
apply cream. If the desire to scratch continues, apply a fingertip amount of ointment to
anal and perianal areas. Use finger cot or disposable gloves if desired. Rub or lightly
scratch (with fingertip, not fingernails) until the itch is satisfied.
• For Anal Fissures: Apply a fingertip amount of cream to the anal area and to the inner
rim of the anus.
• Children under 12 years of age: consult a doctor
• Apply externally to the affected area once or twice daily when pain or irritation from
anal fissures are present or ideally after bowel movement.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,
Isopropyl Palmitate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol,
Stearyl Alcohol

OTC - QUESTIONS SECTION

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

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRANICURA

THE PRURITUS ANI SOLUTION

Anorectal Cream

Net Wt. 2.5 oz. (70 g)

Manufactured for Pranicura, LLC by Sarati International, Inc.
Los Fresnos, Texas 78566

2.5 oz. Jar

Anorectal 013119Anorectal 013119

2.0 oz. Jar

Anorectal 002-03 2 oz btlAnorectal 002-03 2 oz btl

res

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71831-00271831-002-01, 71831-002-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a953a4e0-72e2-4c9f-a0b4-2f3f4e2cf84f3c8b2b16-6890-46d0-9bff-4ae6fc3e07ad2021-11-08WarningsExact identifier
spl set id: 3c8b2b16-6890-46d0-9bff-4ae6fc3e07ad

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.