NDC 78759-002 Kannaco

Pain Relief Cream

NDC Product Code 78759-002

NDC 78759-002-01

Package Description: 100 mL in 1 BOTTLE, PUMP

NDC Product Information

Kannaco with NDC 78759-002 is a a human over the counter drug product labeled by Phm Brands, Llc. The generic name of Kannaco is pain relief cream. 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.

Kannaco 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.

  • MENTHOL, UNSPECIFIED FORM 4.49 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.

  • OSTRICH (UNII: 20N2T27G9I)
  • ALOE (UNII: V5VD430YW9)
  • WATER (UNII: 059QF0KO0R)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
  • AMERICAN ELDERBERRY (UNII: 7610Y219OC)
  • AUCUBIN (UNII: 2G52GS8UML)
  • CAT'S CLAW (UNII: 9060PRM18Q)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • LEMON BALM OIL (UNII: MJ76269K9S)
  • EQUISETUM ARVENSE STEM OIL (UNII: 93G94AM8DM)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
  • CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • DANDELION HONEY (UNII: Z9305QFA72)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • ALCOHOL (UNII: 3K9958V90M)
  • CUCUMBER SEED OIL (UNII: AKP926H71P)
  • EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
  • SESAME OIL (UNII: QX10HYY4QV)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • AVOCADO OIL (UNII: 6VNO72PFC1)

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: part346 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: 02-01-2021 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 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.

Kannaco Product Label Images

Kannaco 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

Purpose

Topical Analgesic

Use

For the temporary relief of minor aches and pains of sore muscles and joints associated with: Backache, Arthritis, Strains, Bruises

Warnings

For External Use Only

Otc - When Using

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged skin. Do not apply to irritated skin or if excessive irritation develops. Do not bandage or use with a heating pad. Wash hands after used with cool water.

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 accidently ingested, get medical help or contact Poison Control immediately.

Otc - Pregnancy Or Breast Feeding

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

Directions

Apply to affected area 1 to 2 times daily

Other Information

Store in a cool, dry place

Inactive Ingredients

Aloe Leaf Juice, Water, Full Spectrum Hemp Extract (Aerial Parts), Ostrich Oil, Sunflower Oil, Isopropyl Palmitate, Glyceryl Stearate, Cetyl Alcohol, Stearic Acid, Glycerin, Phenoxyethanol, Shea Butter, Tocopheryl Acetate, Xanthan Gum, Panthenol, Jojoba Oil, Ethylhexylglycerin, Tea Tree Extract, Alcohol, Cucumber Extract, Evening Primrose Oil, Avocado Oil, Sesame Seed Oil, Lavender Oil, Sweet Orange oil, Lemon Balm Extract, Cat's Claw Extract, Chamomile Extract, Elderberry Extract, Eyebright Extract, Marigold Extract, Geranium Extract, Gotu Kola Extract, Dandelion Extract

* Please review the disclaimer below.