NDC 73048-001 Zen Hemp Balm

Camphor, Eucalyptus Oil, Menthol, Methyl Salicylate

NDC Product Code 73048-001

NDC 73048-001-01

Package Description: 20 g in 1 JAR

NDC Product Information

Zen Hemp Balm with NDC 73048-001 is a a human over the counter drug product labeled by Zen Enterprises Llc. The generic name of Zen Hemp Balm is camphor, eucalyptus oil, menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Zen Enterprises Llc

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.


Zen Hemp 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.

  • CAMPHOR (NATURAL) 11 g/100g
  • EUCALYPTUS OIL 10 g/100g
  • MENTHOL 8 g/100g
  • METHYL SALICYLATE 10 g/100g

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.

  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • CLOVE OIL (UNII: 578389D6D0)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • BORNEOL (UNII: M89NIB437X)
  • CITRONELLA OIL (UNII: QYO8Q067D0)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • HEMP (UNII: TD1MUT01Q7)

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: Zen Enterprises Llc
Labeler Code: 73048
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: 04-22-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Zen Hemp Balm Product Label Images

Zen Hemp 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

Otc - Active Ingredient

Active Ingredients....................................PurposeCamphor 11%............................................Topical AnalgesicEucalyptus Oil 10%....................................Anti-InflammatoryMenthol 8%................................................Topical AnalgesicWintergreen Oil (Methyl Salicylate) 10%....Topical Analgesic

Otc - Purpose

Active Ingredients......................................PurposeCamphor 11%............................................Topical AnalgesicEucalyptus Oil 10%....................................Anti-InflammatoryMenthol 8%................................................Topical AnalgesicWintergreen Oil (Methyl Salicylate) 10%....Topical Analgesic

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion.If swallowed, seek medical attention or consult a physician immediately.

Indications & Usage

  • Uses: Temporarily relieves minor aches & pains related toheadachesbackachesjoint and muscle paincramps and spasmssprains and other sports related injuries

Dosage & Administration

Directions:
Use only as directed. Apply generously to affected area 3 to 4 times daily. Children under 12, consult a doctor before use.

Inactive Ingredient

Inactive IngredientsNarayani Oil, Clove Oil, Nutmeg Oil, Cassia Oil, Paraffin Wax, Cinnamon Oil, Peppermint Oil, White Petroleum Jelly, Borneol, Light Liquid Paraffin, Citronella Oil, Beeswax

Warnings

  • CAUTIONSFor external use onlyWhen using this product discontinue use if excessive irritation of the skin develops. Avoid contact wih eyes and mucous membranes, Do not bandage. Do not use with a heating pad. Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 dayssymptoms clear up and occur again within a few days orexcessive skin irritation occurs

* Please review the disclaimer below.

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