Viobin, LLC by PHM Brands, LLC / Viobin, LLC

Viobin, LLC by

Drug Labeling and Warnings

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

Drug Details [pdf]

VIOBIN, LLC- 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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4% Menthol

Topical analgesic

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

For external use only.

Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged skin. Do not apply to irritated skin or if excessive irritation develops. Do not bandage or use with a heating pad. Wash hands wafter use with cool water.

If a contidtion worsens, or if symptoms persist for more than 7 days or clear up and reoccur.

If swallowed, get medical help or contact Poison Control immediately.

Ask a health professional before use.

Apply to affected area 1 to 2 times daily.

Store in a cool, dry place, Do not use if seal is missing or broken.

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

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

VIOBIN, LLC 
pain relief ointment lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78759-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)	0.9 g  in 50 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.09 g  in 50 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.34 g  in 50 mL
WATER (UNII: 059QF0KO0R)	31.39 g  in 50 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	1.395 g  in 50 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	0.9 g  in 50 mL
COCONUT OIL (UNII: Q9L0O73W7L)	9.005 g  in 50 mL
STEARIC ACID (UNII: 4ELV7Z65AP)	0.9 g  in 50 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.09 g  in 50 mL
CANNABIDIOL (UNII: 19GBJ60SN5)	2.963 g  in 50 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78759-005-04	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/23/2021	12/31/2021

Labeler - PHM Brands, LLC (081176131)

Registrant - Viobin, LLC (805279234)

Establishment
Name	Address	ID/FEI	Business Operations
Viobin, LLC		805279234	manufacture(78759-005)

Revised: 1/2022

Document Id: d505e361-936b-5552-e053-2a95a90aaea7

34390-5

Set id: c744f4af-cd2a-5d78-e053-2995a90aac32

Version: 2

Effective Time: 20220107