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  5. Label Information: Puriya Antifungal Balm

FDA Label for Puriya Antifungal Balm

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PRODUCT LABELING

Puriya Antifungal Balm Product Label

The following document was submitted to the FDA by the labeler of this product Raining Rose, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DRUG FACTS


Otc - Active Ingredient



Active Ingredient
Zinc Undecylenate 10%


Otc - 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 


Otc - Do Not Use



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


Otc - When Using



When using this product • Do not get into eyes


Otc - 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)


Otc - 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


Otc - 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 [email protected]

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* Please review the disclaimer below.