Pranicura by Pranicura, LLC / Sarati International, Inc.
Pranicura by
Drug Labeling and Warnings
Pranicura by is a Otc medication manufactured, distributed, or labeled by Pranicura, LLC, Sarati International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PRANICURA- glycerin, calamine, aluminum hydroxide, menthol ointment
Pranicura, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active Ingredients Purposes
Glycerin 25% …………………………………………………..……..….. Protectant
Calamine 20% …………………………………………..…….. Protectant/Anti-Itch
Aluminum Hydroxide Gel 5% ……………………………….. Protectant/Anti-Itch
Menthol 1% …………………………………………………………..….... Analgesic
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
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
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, or other symptoms develop or increase
● do not put this product into rectum by using fingers or any mechanical device or
applicator.
Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away
Directions
Apply a fingertip amount of cream to the anal area and to the inner rim of the anus.
Apply externally to the affected area once or twice daily when pain or irritation from anal fissures are present or ideally after bowel movement.
Inactive Ingredients
acrylates/C 10-30 alkyl acrylate crosspolymer, beeswax, cetearyl alcohol, coconut oil,
deionized water, isopropyl palmitate, phenoxyethanol, polysorbate 20, propylene glycol,
SD alcohol, stearyl alcohol
PRANICURA
THE PRURITUS ANI SOLUTION
Anorectal Cream
Net Wt. 2.5 oz. (70 g)
Drug Facts
Active Ingredients Purposes
Glycerin 25% ...................................................................... Protectant
Calamine 20% .................................................... Protectant/Anti-Itch
Aluminum Hydroxide Gel 5% ................................ Protectant/Anti-Itch
Menthol 1% ......................................................................... Analgesic
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 most anorectal conditions ● For the temporary relief
of irritation and burning PULL HERE →
Drug Facts (continued)
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 daily recommended 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, or other symptoms develop or increase
● do not put this product into rectum by using fingers or any mechanical device or
applicator. →
Drug Facts (continued)
● 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
Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away
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 paper or a soft
cloth before application of this product →
Drug Facts (continued)
● 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 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 until pain or irritation from
anal fissures are present or ideally after bowel movement.
→
Drug Facts (continued)
Other Information store at 15o-30o C (59o-86o F)
Inactive Ingredients
acrylates/C 10-30 alkyl acrylate crosspolymer, beeswax, cetearyl alcohol, coconut oil,
deionized water, isopropyl palmitate, phenoxyethanol, polysorbate 20, propylene glycol,
SD alcohol, stearyl alcohol
Questions or Comments? Call weekdays 9 AM to 5 PM CST at 763-537-3419
Manufactured for Pranicura, LLC by Sarati International, Inc.
Los Fresnos, Texas 78566
| PRANICURA
glycerin, calamine, aluminum hydroxide, menthol ointment |
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| Labeler - Pranicura, LLC (080842423) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sarati International, Inc. | 160219770 | manufacture(71831-001) | |