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

  • NDC Code(s): 71831-002-01, 71831-002-03
  • Packager: Pranicura, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 8, 2020

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

  • 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,
    Isopropyl Palmitate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol,
    Stearyl Alcohol

  • QUESTIONS

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

  • Principal Display Package

    PRANICURA

    THE PRURITUS ANI SOLUTION

    Anorectal Cream

    Net Wt. 2.5 oz. (70 g)

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

    2.5 oz. Jar

    Anorectal 013119

    2.0 oz. Jar

    Anorectal 002-03 2 oz btl

    res

  • INGREDIENTS AND APPEARANCE
    PRANICURA 
    glycerin, kaolin, calamine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71831-002
    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)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71831-002-0170 g in 1 JAR; Type 0: Not a Combination Product01/31/2019
    2NDC:71831-002-0356 g in 1 JAR; Type 0: Not a Combination Product01/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/01/2019
    Labeler - Pranicura, LLC (080842423)
    Registrant - Pranicura, LLC (080842423)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sarati International, Inc.160219770manufacture(71831-002)