Viobin by PHM Brands, LLC / Viobin, LLC

Viobin by

Drug Labeling and Warnings

Viobin 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- cooling gel 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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Topical Analgesic

4% menthol

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

For external use only

Avoid contact with eyes or mucous membranes

Don ot apply to wounds or damaged skin

Do not apply to irriated skin or if ecessive irritation develops

Do not bandage or use with a heating pad

Wash hands after use with cool water

If conditions 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 a daily.

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

Organic Aloe Leaf Juice, Broad Spectrum Hemp Extract (CBD, CBG, CBN, CBDV)* (Aerial Parts), Meadowfoam Seed Oil, Capsicum Fruit Oleoresin, 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, Organic Alcohol, Phenoxyethanol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate.

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

VIOBIN 
cooling gel roll-on gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78759-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.69 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
BASIL OIL (UNII: Z129UMU8LE)	0.16 g  in 60 mL
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)	0.319 g  in 60 mL
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)	0.16 g  in 60 mL
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)	0.16 g  in 60 mL
PINE NEEDLE OIL (PINUS MUGO) (UNII: 6KF1RLN1CI)	0.16 g  in 60 mL
SPEARMINT OIL (UNII: C3M81465G5)	0.16 g  in 60 mL
OREGANO LEAF OIL (UNII: 7D0CGR40U1)	0.16 g  in 60 mL
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)	0.319 g  in 60 mL
CAPSICUM OLEORESIN (UNII: UW86K581WY)	0.16 g  in 60 mL
ROSEMARY OIL (UNII: 8LGU7VM393)	0.16 g  in 60 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	0.16 g  in 60 mL
CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)	0.16 g  in 60 mL
EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)	0.16 g  in 60 mL
BLACK PEPPER OIL (UNII: U17J84S19Z)	0.16 g  in 60 mL
CINNAMON LEAF OIL (UNII: S92U8SQ71V)	0.16 g  in 60 mL
GRAPEFRUIT OIL (UNII: YR377U58W9)	0.16 g  in 60 mL
JUNIPER BERRY OIL (UNII: SZH16H44UY)	0.16 g  in 60 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.319 g  in 60 mL
ALCOHOL (UNII: 3K9958V90M)	0.018 g  in 60 mL
CANNABIDIOL (UNII: 19GBJ60SN5)	3.506 g  in 60 mL
EDETATE SODIUM (UNII: MP1J8420LU)	0.16 g  in 60 mL
ALOE EMODIN (UNII: C8IYT9CR7C)	46.391 g  in 60 mL
WITCH HAZEL (UNII: 101I4J0U34)	0.319 g  in 60 mL
GINGER OIL (UNII: SAS9Z1SVUK)	0.16 g  in 60 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.319 g  in 60 mL
CARBOMER 934 (UNII: Z135WT9208)	0.319 g  in 60 mL
CAJUPUT OIL (UNII: J3TO6BUQ37)	0.16 g  in 60 mL
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)	1.6 g  in 60 mL
CITRONELLA OIL (UNII: QYO8Q067D0)	0.16 g  in 60 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78759-007-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/22/2021	12/31/2021

Labeler - PHM Brands, LLC (081176131)

Registrant - Viobin, LLC (805279234)

Establishment
Name	Address	ID/FEI	Business Operations
Viobin, LLC		805279234	manufacture(78759-007)

Revised: 1/2022

Document Id: d505da78-c670-0573-e053-2995a90a3844

34390-5

Set id: c72d338b-6283-5a4a-e053-2995a90ab372

Version: 2

Effective Time: 20220107