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Drug Facts
Pranicura 5 Cream
FDA Label NDC 67676-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sarati International, Inc. for the product Pranicura 5 (NDC 67676-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Glycerin 25%
Kaolin 12.5%
Calamine 12.5%
Menthol 1%
Otc - Purpose
Purposes
Glycerin ....................................................Protectant
Kaolin .........................................Protectant/Anti-Itch
Calamine ....................................Protectant/Anti-Itch
Menthol .....................................................Analgesic
Indications & 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
Warnings
Warnings
For rectal use only
Do not useunless a prior doctor’s diagnosis of anorectal condition has been made
When using this productdo 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison
Control Center right away
Dosage & Administration
Other Informationstore at 15-30° C (59-86° F)
Other Safety Information
Other Informationstore at 15-30° C (59-86° F)
Inactive Ingredient
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
Otc - Questions
Questions or Comments?Call weekdays 9 AM to 5 PM CST at 763-537-3419
Package Label.Principal Display Panel
PRANICURA 5
Ultimate Relief from Pruritus Ani, Fissures and Hemmorhoids
Available only at: www.pranicura.com
Net Wt. 2.1 oz. (60 g)
RES
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