NDC 65692-0308 Puriya Antifungal Balm

Zinc Undecylenate

NDC Product Code 65692-0308

NDC 65692-0308-1

Package Description: 1 JAR in 1 BOX > 5.7 g in 1 JAR

NDC Product Information

Puriya Antifungal Balm with NDC 65692-0308 is a a human over the counter drug product labeled by Raining Rose, Inc.. The generic name of Puriya Antifungal Balm is zinc undecylenate. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2553201.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Puriya Antifungal Balm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Raining Rose, Inc.
Labeler Code: 65692
FDA Application Number: part333C What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-04-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Puriya Antifungal Balm Product Label Images

Puriya Antifungal Balm Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

DRUG FACTS

Otc - Active Ingredient

Active IngredientZinc Undecylenate 10%

Otc - Purpose

PurposeAntifungal

Indications & Usage

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

Warnings

WarningsFor 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 improvementwithin 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 potentialallergic reaction • Wash affected area and dry thoroughly • Apply a thinlayer over affected area twice dally (morning and night) or as directed by adoctor • Supervise children in use of this product • For athlete's foot, payspecial attention to spaces between the toes, wear well-fitting, ventilatedshoes and change socks at least once dally • For athlete's foot andringworm, use dally for 4 weeks. For jock itch, use dally for 2 weeks • Ifcondition persists longer, ask a doctor • This product is not effective onscalp or nails.

Other Safety Information

Other infonnationStore 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, LavandulaAngustifolia (Lavender) Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.*Derived from plant sources

Otc - Questions

Questions? Comments? 844-234-1476

Product Labeling

Puriya​®​ANTIFUNGAL BALMTreats Athlete's Foot | Jock Itch | RingwormPhysician Formulated |16 Powerful BotanicalsZinc Undecylenate         Net wt 2.0 oz / 57 gDistributed by:IPC Republic, Inc. DBA PuriyaLos Angeles, CA 90013844-234-1476www.puriya.comQuestions? Email [email protected]

* Please review the disclaimer below.