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 ointment lotion 
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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Active Ingredient(s)

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

Purpose

Topical Analgesic

Use

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

Warnings

For External Use Only

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

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

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and recur.

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

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

Directions

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

Children: Consult a health care provider before use

Other Information

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

Inactive Ingredients

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)

PUREKANA 
pain relief ointment lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78759-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3.88 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.026 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)	7.33 g  in 100 mL
COCONUT OIL (UNII: Q9L0O73W7L)	15.74 g  in 100 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	1.57 g  in 100 mL
SHEA BUTTER (UNII: K49155WL9Y)	5.75 g  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	2.44 g  in 100 mL
POLYSORBATE 60 (UNII: CAL22UVI4M)	1.57 g  in 100 mL
CANNABIDIOL (UNII: 19GBJ60SN5)	0.82 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.59 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.16 g  in 100 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.16 g  in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)	0.96 g  in 100 mL
WATER (UNII: 059QF0KO0R)	54.84 g  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78759-004-03	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/18/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/18/2021	12/31/2021

Labeler - PHM Brands, LLC (081176131)

Registrant - Viobin, LLC (805279234)

Establishment
Name	Address	ID/FEI	Business Operations
Viobin, LLC		805279234	manufacture(78759-004) , pack(78759-004)

Revised: 1/2022

Document Id: d505e9ba-2a85-83fa-e053-2995a90a420b

34390-5

Set id: c210bb1c-eeaa-cdea-e053-2995a90adcf8

Version: 8

Effective Time: 20220107