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| Product NDC Code | 65692-0308 | ||||
|---|---|---|---|---|---|
| Drug Name | Puriya antifungal balm |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2553201 | ||||
| Application Number | M005 | ||||
| Labeler Name | Raining Rose, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Undecylenate 10%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • Treats athlete's loot, jock itch and ringworm • Relieves itchlng, burning, cracking and scaling which accompany these conditions
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Puriya Antifungal Balm ZINC UNDECYLENATE ZINC UNDECYLENATE UNDECYLENIC ACID MACADAMIA OIL SAFFLOWER OIL OLIVE OIL CANDELILLA WAX TEA TREE OIL AVOCADO OIL COCONUT OIL EUCALYPTUS OIL CETOSTEARYL ALCOHOL ALMOND OIL PELARGONIUM GRAVEOLENS FLOWER OIL RICE BRAN SUNFLOWER OIL ROSEMARY TOCOPHEROL PUMPKIN SEED OIL LEVOMENOL LAVENDER OIL ORANGE OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 Jar res 0308 box 0308 Jar
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do oot use In children under 2 years of age unless directed by doctor
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children • If swallowed, get medical help or call a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other infonnation Store between 68°F - 78°F (20°C - 25°C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Comments? 844-234-1476
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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)
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • Do not get into eyes
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API