PRANICURA 5- glycerin, kaolin, calamine, menthol cream

Pranicura 5 by

Drug Labeling and Warnings

Pranicura 5 by is a Otc medication manufactured, distributed, or labeled by PRANICURA GROUP LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients

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

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 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

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

QUESTIONS

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

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

INGREDIENTS AND APPEARANCE

PRANICURA 5 
glycerin, kaolin, calamine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71831-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	25.0 g  in 100 g
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO)	KAOLIN	12.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71831-004-01	60 g in 1 JAR; Type 0: Not a Combination Product	10/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	10/18/2021

Labeler - PRANICURA GROUP LLC (118320102)