PureKana

Manufacturer
PHM Brands, LLC | Viobin, LLC
Effective date
2021-07-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:41:26

Label at a glance#

ProductPureKana
Active ingredientMENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure12 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External Use Only

Do not use: on wounds or damaged skin, if seal is missing or broken

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: Apply to affected area no more than 3 to 4 times daily

Children: Consult a health care provider before use

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lotion LabelLotion Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78759-00478759-004-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d505e9ba-2a85-83fa-e053-2995a90a420bc210bb1c-eeaa-cdea-e053-2995a90adcf82022-01-07WarningsExact identifier
spl set id: c210bb1c-eeaa-cdea-e053-2995a90adcf8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.