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.

----------

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 600 120

PUREKANA 
pain relief roll-on gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78759-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.024 g  in 90 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.85 g  in 90 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78759-006-0290 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/202112/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/20/202112/31/2021
Labeler - PHM Brands, LLC (081176131)
Registrant - Viobin, LLC (805279234)
Establishment
NameAddressID/FEIBusiness Operations
Viobin, LLC805279234manufacture(78759-006)

Revised: 1/2022
Document Id: d505c0ee-ec95-0f5e-e053-2a95a90a0424
Set id: c702caf9-1eb1-1a16-e053-2a95a90aaf2a
Version: 2
Effective Time: 20220107
 
PHM Brands, LLC