Label: PURIYA ANTIFUNGAL BALM- zinc undecylenate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredient
    Zinc Undecylenate 10%

  • PURPOSE

    Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses• Treats athlete's loot, jock itch and ringworm • Relieves itchlng,
    burning, cracking and scaling which accompany these conditions

  • WARNINGS

    Warnings

    For external use only 

  • DO NOT USE

    Do oot use In children under 2 years of age unless directed by doctor

  • WHEN USING

    When using this product • Do not get into eyes

  • STOP USE

    Stop use and ask doctor if • Irritation occurs • there is no improvement
    within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock Itch)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children • If swallowed, get medical help or call a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions • Test asmall area on your skin to check for any potential
    allergic reaction • Wash affected area and dry thoroughly • Apply a thin
    layer over affected area twice dally (morning and night) or as directed by a
    doctor • Supervise children in use of this product • For athlete's foot, pay
    special attention to spaces between the toes, wear well-fitting, ventilated
    shoes and change socks at least once dally • For athlete's foot and
    ringworm, use dally for 4 weeks. For jock itch, use dally for 2 weeks • If
    condition persists longer, ask a doctor • This product is not effective on
    scalp or nails.

  • OTHER SAFETY INFORMATION

    Other infonnation
    Store between 68°F - 78°F (20°C - 25°C)

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Macadamia Temifolia (Macadamia) Seed Oil, Carthamus Tinctorius (Safflower)
    Seed Oil, Olea Europaea (Olive) Fruit Oil, Euphorbia Cerifera (Candelilla) Wax,
    Melaleuca Altemifolia (Tea Tree) Leaf Oil, Persea Gratissima (Avocado) Oil,
    Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus Leaf Oil, Cetearyl Alcohol*,
    Prunus Amygdalus Dulcis (Sweet Almond) Oil, Pelargonium Graveolens
    (Geranium) Flower Oil, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus
    (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract,
    Tocopherol, Cucurbita Pepo (Pumpkin) Seed Oil, Bisabolol, Lavandula
    Angustifolia (Lavender) Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.
    *Derived from plant sources

  • QUESTIONS

    Questions? Comments? 844-234-1476

  • Product Labeling

    puriya​®

    ANTIFUNGAL BALM

    Treats Athlete's Foot | Jock Itch | Ringworm
    Physician Formulated |16 Powerful Botanicals

    Zinc Undecylenate         Net wt 2.0 oz / 57 g

    Distributed by:
    IPC Republic, Inc. DBA Puriya
    Los Angeles, CA 90013
    844-234-1476

    www.puriya.com
    Questions? Email usatservice@Puriya.com

    Box

    0308 box

    Jar

    0308 Jar

    res

  • INGREDIENTS AND APPEARANCE
    PURIYA ANTIFUNGAL BALM 
    zinc undecylenate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE5.7 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    MACADAMIA OIL (UNII: 515610SU8C)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    RICE BRAN (UNII: R60QEP13IC)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY (UNII: IJ67X351P9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0308-11 in 1 BOX06/04/2021
    15.7 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/04/2021
    Labeler - Raining Rose, Inc. (083819404)