PureKana by PHM Brands, LLC / Viobin, LLC

PureKana by

Drug Labeling and Warnings

PureKana by is a Otc medication manufactured, distributed, or labeled by PHM Brands, LLC, Viobin, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PUREKANA- pain relief roll-on gel 
PHM Brands, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Purpose: Toplical Analgesic

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

For external use only

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 healthcare provider. Do not bandage tightly.

On wounds or damaged skin. If seal is missing or broken.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask a healthcare provider before use.

Adults: Apply to affected area no more than 3-4 times daily. Children: Consult a healthcare provider before use.

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

Inactive Ingredients: Organic Aloe Leaf Juice, Meadowfoam Seed Oil, Methylsulfonylmethane (MSM), Broad Spectrum Hemp Extract (CBD, CBG, CBN, CBDV*) (Aerial Parts), White Camphor Bark Oil, Sweet Basil Leaf Oil, Black Pepper Oil, Roman Chamomile Flower Oil, German Chamomile Flower Oil, Cinnamon Leaf Oil, Citronella Oil, Eucalyptus Leaf Oil, Helichrysum Flower Oil, Ginger Root Oil, Pink Grapefruit Peel Oil, Juniper Berry Oil, Lemongrass Oil, Peppermint Oil, Pine Needle Oil, Cajeput Oil, Rosemary Leaf Oil, Spearmint Oil, Wild Oregano Oil, Glycerin, Witch Hazel Water, Phenoxyethanol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate.

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

Menthol 4%

Capsaicin 0.0.25%

PUREKANA 
pain relief roll-on gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78759-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.024 g  in 90 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.85 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
BLACK PEPPER OIL (UNII: U17J84S19Z)	0.244 g  in 90 mL
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)	0.487 g  in 90 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	0.244 g  in 90 mL
CITRONELLA OIL (UNII: QYO8Q067D0)	0.244 g  in 90 mL
ROSEMARY OIL (UNII: 8LGU7VM393)	0.244 g  in 90 mL
GINGER OIL (UNII: SAS9Z1SVUK)	0.244 g  in 90 mL
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)	0.244 g  in 90 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.487 g  in 90 mL
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)	0.487 g  in 90 mL
CANNABINOL (UNII: 7UYP6MC9GH)	0.0073 g  in 90 mL
PINE NEEDLE OIL (PINUS MUGO) (UNII: 6KF1RLN1CI)	0.244 g  in 90 mL
OREGANO LEAF OIL (UNII: 7D0CGR40U1)	0.244 g  in 90 mL
CAJUPUT OIL (UNII: J3TO6BUQ37)	0.244 g  in 90 mL
CINNAMON LEAF OIL (UNII: S92U8SQ71V)	0.244 g  in 90 mL
WITCH HAZEL (UNII: 101I4J0U34)	0.487 g  in 90 mL
CARBOMER 934 (UNII: Z135WT9208)	0.487 g  in 90 mL
GRAPEFRUIT OIL (UNII: YR377U58W9)	0.244 g  in 90 mL
JUNIPER BERRY OIL (UNII: SZH16H44UY)	0.244 g  in 90 mL
SPEARMINT OIL (UNII: C3M81465G5)	0.244 g  in 90 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.487 g  in 90 mL
ALOE EMODIN (UNII: C8IYT9CR7C)	70.71 g  in 90 mL
CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)	0.244 g  in 90 mL
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)	0.244 g  in 90 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.487 g  in 90 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)	0.86 g  in 90 mL
CANNABIGEROL (UNII: J1K406072N)	0.1338 g  in 90 mL
CANNABIDIOL (UNII: 19GBJ60SN5)	0.66 g  in 90 mL
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)	2.44 g  in 90 mL
BASIL OIL (UNII: Z129UMU8LE)	0.244 g  in 90 mL
EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)	0.244 g  in 90 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78759-006-02	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/20/2021	12/31/2021

Labeler - PHM Brands, LLC (081176131)

Registrant - Viobin, LLC (805279234)

Establishment
Name	Address	ID/FEI	Business Operations
Viobin, LLC		805279234	manufacture(78759-006)

Revised: 1/2022

Document Id: d505c0ee-ec95-0f5e-e053-2a95a90a0424

34390-5

Set id: c702caf9-1eb1-1a16-e053-2a95a90aaf2a

Version: 2

Effective Time: 20220107