NDC 73498-025 Natures Willow Bug Bite Patch

Calendula, Salix Alba

NDC Product Code 73498-025

NDC 73498-025-01

Package Description: 4 POUCH in 1 BOX > 10 PATCH in 1 POUCH

NDC Product Information

Natures Willow Bug Bite Patch with NDC 73498-025 is a a human over the counter drug product labeled by Wb Ventures Llc. The generic name of Natures Willow Bug Bite Patch is calendula, salix alba. The product's dosage form is patch and is administered via topical form.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Natures Willow Bug Bite Patch 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.

  • ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
  • LINOLENIC ACID (UNII: 0RBV727H71)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • MENTHOL (UNII: L7T10EIP3A)
  • GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)

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: Wb Ventures Llc
Labeler Code: 73498
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 12-08-2021 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.

Natures Willow Bug Bite Patch Product Label Images

Natures Willow Bug Bite Patch 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

Active Ingredients

Calendula Officinalis Flower Extract 0.002 mgSalix Alba (Willow) Bark Extract 0.004 mg

Purpose

Purpose*Calendula Officinalis Flower Extract 0.002 mgReduces scarring, speeds healingSalix Alba (Willow) Bark Extract 0.004 mgTopical analgesic

Uses

Uses*For the temporary relief of symptoms associated with insect bites.

Warnings

For external use only. Avoid contact with eyes, mucous membranes, damaged skin or wounds.
Do not use if you are allergic to any ingredients in this product or by persons with known sensitivity to aspirin.
Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.
If pregnant or breast-feeding, ask a healthcare professional before use.
Discontinue treatment in case of skin irritation, redness or rash occurs.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center immediately.

Directions

Adults and children over 12 years of age:1. Clean and dry the affected area.2. Peel off a patch from the transparent backing.3. Apply carefully on the affeced area. To prevent touching the patch with your fingers, use the side tab.4. Keep the patch on until the nuisance is gone. Do not exceed 8 hours of application.Children under 12 years of age: consult a physician

Other Information

  • Damaged packaging could compromise the operation and safety of the product.Do not use if packaging is broken or punctured.Disposable Single Use.Store in cool, dry place.

Inactive Ingredients

Acrylates Copolymer, Eucalyptus Globulus Leaf Oil, Glycine Soja Oil, Helichrysum Italicum Flower Extract, Lavandula Angustifolia Oil, Limonene, Linalool, Linseed Acid, Mentha Piperita (Peppermint) Oil, Menthol, Oleyl Alcohol, Pelargonium Graveolens Oil, Propylene Glycol, Tocopheryl Acetate, Vitis Vinifera Seed Oil, Zanthoxylum Bungeanum Fruit Extract

Other

*This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

* Please review the disclaimer below.