Label: PRANICURA 5- glycerin, kaolin, calamine, menthol cream

  • NDC Code(s): 67676-007-01
  • Packager: Sarati International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

If you are a consumer or patient please visit this version.

  • 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 useunless a prior doctor’s diagnosis of anorectal condition has been made
    When using this productdo 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 Informationstore at 15-30º C (59-86º F)

  • OTHER SAFETY INFORMATION

    Other Informationstore 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)

    Pranicura 5

    image description

    RES

  • INGREDIENTS AND APPEARANCE
    PRANICURA 5 
    glycerin, kaolin, calamine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67676-007
    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 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:67676-007-0160 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 - Sarati International, Inc. (160219770)