{"active_ingredient":["Drug Facts Active Ingredients Glycerin 25% Calamine 20% Aluminum Hydroxide Gel 5% Menthol 1%"],"do_not_use":["Do not use unless a prior doctor's diagnosis of anorectal condition has been made"],"dosage_and_administration":["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."],"effective_time":"20191122","id":"0c125575-089d-4de3-948c-56cf65d0e048","inactive_ingredient":["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"],"indications_and_usage":["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"],"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"],"openfda":{},"other_safety_information":["Other Information store at 15o-30o C (59o-86o F)"],"package_label_principal_display_panel":["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 Final Label Proof for Pranicura"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding , ask a health professional before use"],"purpose":["Purposes Protectant Protectant/Anti-Itch Analgesic"],"questions":["Questions or Comments? Call weekdays 9 AM to 5 PM CST at 763-537-3419"],"set_id":"5d80e97e-ff00-c396-e053-2a91aa0a923e","spl_product_data_elements":["Pranicura Glycerin, Calamine, Aluminum Hydroxide, Menthol WATER PROPYLENE GLYCOL CETOSTEARYL ALCOHOL COCONUT OIL ALCOHOL YELLOW WAX PHENOXYETHANOL POLYSORBATE 20 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERIN GLYCERIN ZINC OXIDE ZINC OXIDE STEARYL ALCOHOL ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MENTHOL MENTHOL ISOPROPYL PALMITATE"],"stop_use":["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."],"version":"5","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"],"when_using":["When using this product do not exceed the daily recommended dosage unless directed by a doctor"]}