NDC 72680-012 Uncle Buds Hemp Pain Relief

Trolamine Salicylate Salve

NDC Product Code 72680-012

NDC 72680-012-01

Package Description: 1 JAR in 1 CARTON > 57 g in 1 JAR

NDC Product Information

Uncle Buds Hemp Pain Relief with NDC 72680-012 is a a human over the counter drug product labeled by Cbh International. The generic name of Uncle Buds Hemp Pain Relief is trolamine salicylate salve. The product's dosage form is salve and is administered via topical form.

Labeler Name: Cbh International

Dosage Form: Salve - A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).

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.

Uncle Buds Hemp Pain Relief 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.

  • TROLAMINE SALICYLATE 100 mg/g

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.

  • MANDARIN OIL (UNII: NJO720F72R)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CANOLA OIL (UNII: 331KBJ17RK)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

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: Cbh International
Labeler Code: 72680
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-11-2021 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".

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Uncle Buds Hemp Pain Relief Product Label Images

Uncle Buds Hemp Pain Relief 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 Ingredient

Trolamine salicylate 10%

Purpose

Topical analgesic

Use

  • Temporary relief of minor ached and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only.

When Using This Product

  • Avoid contact with eyesDo not apply to wounds or damaged skinDo not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsensSymptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Other Information

Store at room temperature. Avoid excessive heat.

Inactive Ingredients

Avocado Oil, Cannabis Sative Seed Oil, Canola Oil, Mandarin Oil, PEG-40 Castor Oil, Polysorbate 20, Safflower Oil, Sunflower Oil, Tocopherol, Yellow Wax

Questions?

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* Please review the disclaimer below.