NDC 78759-004 Purekana

Pain Relief Ointment

NDC Product Code 78759-004

NDC 78759-004-03

Package Description: 100 mL in 1 BOTTLE, PUMP

NDC Product Information

Purekana with NDC 78759-004 is a a human over the counter drug product labeled by Phm Brands, Llc. The generic name of Purekana is pain relief ointment. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Phm Brands, Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Purekana 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.

  • CAPSAICIN .026 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)

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: Phm Brands, Llc
Labeler Code: 78759
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: 05-18-2021 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.

Purekana 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(S)

Menthol 4% v/v. Purpose:Topical Analgesic; Capsaicin 0.025% Purpose: Topical Analgesic


Topical Analgesic


For the temporary relief of minor aches and pains of sore muscles and joints associated with smple backache, arthritis, strains, bruises, and sprains.


For External Use OnlyDo not use: on wounds or damaged skin, if seal is missing or broken

Otc - When Using

Do not apply to irritated skin or if excessive irritation develops, avoid contact with eyes or mucous membranes, if condition worsens, or if symptoms persist more than 7 days or clear up and reoccur within a few days, discontinue the use of this product and consult a health care provider, do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and recur.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care provider before use


Adults: Apply to affected area no more than 3 to 4 times dailyChildren: Consult a health care provider before use

Other Information

Store at 20-25C (68-77F)

Inactive Ingredients

Water, Organic Coconut Oil, Stearic Acid, Shea Butter, Emulsifying Wax (Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60), Mehtylsulfonylmethane (MSM), Broad Spectrum Hemp Extract (CBD, CBG, CBN, CBDV*) (Aerial Parts), Phenoxyethanol, Xanthan Gum, Tetrasodium Glutamate Diacetate* CBD (Cannabidiol), CBG (Cannabigerol), CBN (Cannabinol), CBDV (Cannabidivarin)

* Please review the disclaimer below.