FDA.reportPublic FDA data

Viobin, LLC

Manufacturer
PHM Brands, LLC | Viobin, LLC
Effective date
2021-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:39:45

Label at a glance#

ProductViobin, LLC
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

4% Menthol

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Apply to affected area 1 to 2 times daily.

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BS Viobin 50mL Menthol LotionBS Viobin 50mL Menthol Lotion

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78759-00578759-005-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 60CAL22UVI4MIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
COCONUT OILQ9L0O73W7LIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CANNABIDIOL19GBJ60SN5IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d505e361-936b-5552-e053-2a95a90aaea7c744f4af-cd2a-5d78-e053-2995a90aac322022-01-07WarningsExact identifier
spl set id: c744f4af-cd2a-5d78-e053-2995a90aac32

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.