PRANICURA 5- glycerin, kaolin, calamine, menthol cream 
PRANICURA GROUP LLC

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PRANICURA 5

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

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

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

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

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

PRANICURA 5

​Ultimate Relief from Pruritus Ani, Fissures and Hemmorhoids

Available only at: www.pranicura.com

Net Wt. 2.1 oz. (60 g)

Pranicura 5

image description

RES

PRANICURA 5 
glycerin, kaolin, calamine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71831-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN25.0 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) MENTHOL1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
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:71831-004-0160 g in 1 JAR; Type 0: Not a Combination Product10/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01510/18/2021
Labeler - PRANICURA GROUP LLC (118320102)

Revised: 12/2023
Document Id: 18687c95-4c7a-48fe-80b0-df86117958da
Set id: af520a58-3f3c-4d28-a41f-3ed8f74da095
Version: 3
Effective Time: 20231213
 
PRANICURA GROUP LLC