PRANICURA II- glycerin, kaolin, calamine, menthol ointment 
PRANICURA GROUP LLC

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Pranicura II

Drug Facts

Active Ingredients

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

Purposes

Glycerin .......... Protectant
Kaolin ............. Protectant/Anti-itch
Calamine ........ Protectant/Anti-itch
Menthol .......... 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

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

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

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

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

Principal Display Package

PRANICURA II

Ultimate Relief from Pruritus Ani, Fissures and Hemmo

Available only at: www.pranicura.com
Net Wt. 2.1 oz. (60 g)

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

Pranicura IIPranicura II

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PRANICURA II 
glycerin, kaolin, calamine, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71831-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN25 g  in 100 g
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO) KAOLIN12.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71831-003-0160 g in 1 JAR; Type 0: Not a Combination Product04/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01501/01/201912/01/2023
Labeler - PRANICURA GROUP LLC (118320102)
Registrant - PRANICURA GROUP LLC (118320102)

Revised: 12/2023
 
PRANICURA GROUP LLC