PRANICURA II- glycerin, kaolin, calamine, menthol ointment

Pranicura II by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

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

Do not use unless a prior doctor's diagnosis of anorectal condition has been made

WHEN USING

When using this product do not exceed the recommended daily dosage unless
directed by a doctor

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, 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

PREGNANCY OR BREAST FEEDING

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

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

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

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INGREDIENTS AND APPEARANCE

PRANICURA II 
glycerin, kaolin, calamine, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71831-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	25 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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71831-003-01	60 g in 1 JAR; Type 0: Not a Combination Product	04/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/01/2019

Labeler - Pranicura, LLC (080842423)

Registrant - Pranicura, LLC (080842423)