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Kannaco - Prescription Drug Labeling

Product NDC Code 78759-002
Drug Name

Kannaco

Type Brand
Active Ingredients
Menthol, unspecified form 4.49 g/100ml
Route TOPICAL
Dosage Form LOTION
Application Number part346
Labeler Name PHM Brands, LLC
Packages
Package NDC Code Description
78759-002-01 100 ml in 1 bottle, pump (78759-002-01)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Menthol 4% v/v. Purpose:Topical Analgesic

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Apply to affected area 1 to 2 times daily

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use For the temporary relief of minor aches and pains of sore muscles and joints associated with: Backache, Arthritis, Strains, Bruises

Purpose

Information about the drug product’s indications for use.
Purpose Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Kannaco Pain Relief Cream OSTRICH ALOE WATER SUNFLOWER OIL ISOPROPYL PALMITATE GLYCERYL STEARATE SE CETYL ALCOHOL XANTHAN GUM ORANGE OIL CHAMOMILE FLOWER OIL AMERICAN ELDERBERRY AUCUBIN CAT'S CLAW .ALPHA.-TOCOPHEROL ACETATE, D- JOJOBA OIL ETHYLHEXYLGLYCERIN TEA TREE OIL LEMON BALM OIL EQUISETUM ARVENSE STEM OIL STEARIC ACID GERANIUM OIL, ALGERIAN TYPE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CALENDULA OFFICINALIS SEED OIL CENTELLA ASIATICA DANDELION HONEY GLYCERIN PHENOXYETHANOL SHEA BUTTER CANNABIDIOL ALCOHOL CUCUMBER SEED OIL EVENING PRIMROSE OIL SESAME OIL LAVENDER OIL PANTHENOL AVOCADO OIL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Lotion Label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If accidently ingested, get medical help or contact Poison Control immediately.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and recur.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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.

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store in a cool, dry place

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For External Use Only

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API