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DRUG FACTS
Puriya Antifungal Balm Cream
FDA Label NDC 84711-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ipc Republic, Inc. for the product Puriya Antifungal Balm (NDC 84711-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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]
Box
84711-box (84711 Box) 
Jar
res
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