FDA.reportPublic FDA data

PureKana

Manufacturer
PHM Brands, LLC | Viobin, LLC
Effective date
2021-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:40:31

Label at a glance#

ProductPureKana
Active ingredientMENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure12 sections

Storage and handling

Store at 20-25C (65-77F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

PureKana 100 mL CBD 1000mg CBG 400mgPureKana 100 mL CBD 1000mg CBG 400mg

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of msucles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

For external use only.

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

On wounds or damaged skin, if seal is missing or broken

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, Consult a healthcare provider before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a healthcare provider before use

DOSAGE & ADMINISTRATION SECTION

Adults: apply to affected area no more than 3-4 times daily.

Children: Consult a healthcare provider before use.

STORAGE AND HANDLING SECTION

Store at 20-25C (65-77F)

INACTIVE INGREDIENT SECTION

Water, Organic Coconut Oil, Stearic Acid, Shea Butter, Emulsifying Wax (Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60), Broad Spectrum Hemp Extract (CBD, CBG, CBN, CBDV*) (Arial Parts), Methylsulfonylmethane (MSM), Phenooxyethanol, Xanthan Gum, Tetrasodium Glutamate Diacetate.

*CBD (Cannabidiol), CBG (Cannabigerol), CBN (Cannabinol), CBDV (Cannabidivarin)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PureKana BS 100 mL CBD 1000mg CBG 400mgPureKana BS 100 mL CBD 1000mg CBG 400mg

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
78759-00478759-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CANNABIGEROLJ1K406072NIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
STEARIC ACID4ELV7Z65APIACT
SHEA BUTTERK49155WL9YIACT
WATER059QF0KO0RIACT
POLYSORBATE 60CAL22UVI4MIACT
CAPSAICINS07O44R1ZMACTIB
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
CANNABIDIOL19GBJ60SN5IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
COCONUT OILQ9L0O73W7LIACT

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
d505e67f-fd4a-1f62-e053-2a95a90a2953c68de052-5133-39c8-e053-2995a90a9c102022-01-07WarningsExact identifier
spl set id: c68de052-5133-39c8-e053-2995a90a9c10

Reported adverse events (FAERS/openFDA)#

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