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#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
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
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
2.0 oz. Jar
res
Products#
Every source-derived product name is available through these pages.
- Pranicura
- GLYCERIN, KAOLIN, CALAMINE, MENTHOL
- GLYCERIN
- KAOLIN
- ZINC OXIDE
- ZINC CATION
- MENTHOL
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- CETOSTEARYL ALCOHOL
- WATER
- ISOPROPYL PALMITATE
- PHENOXYETHANOL
- POLYSORBATE 20
- PROPYLENE GLYCOL
- ALCOHOL
- STEARYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71831-002 | 71831-002-01, 71831-002-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | ACTIB |
| KAOLIN | 24H4NWX5CO | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIM |
| MENTHOL | L7T10EIP3A | ACTIB |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a953a4e0-72e2-4c9f-a0b4-2f3f4e2cf84f | 3c8b2b16-6890-46d0-9bff-4ae6fc3e07ad | 2021-11-08 | Warnings | 3c8b2b16-6890-46d0-9bff-4ae6fc3e07ad |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

