MedPath

Biofreeze

Biofreeze Spray

Approved
Approval ID

00bb462a-27d0-6f74-e063-6394a90a90ec

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

RB Health (US) LLC

DUNS: 081049410

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MENTHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59316-833
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
MENTHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (16)

ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
DENATONIUM BENZOATEInactive
Code: 4YK5Z54AT2
Classification: IACT
TERT-BUTYL ALCOHOLInactive
Code: MD83SFE959
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ILEX PARAGUARIENSIS LEAFInactive
Code: 1Q953B4O4F
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
JUNIPER BERRYInactive
Code: O84B5194RL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MENTHOLActive
Quantity: 105 mg in 1 mL
Code: L7T10EIP3A
Classification: ACTIB
ECHINACEA ANGUSTIFOLIA WHOLEInactive
Code: VB06AV5US8
Classification: IACT
TEA LEAF OILInactive
Code: VC855RRT77
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2016

Package Labeling:

Label

back label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2016

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/19/2016

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2016

Active Ingredients:

Menthol 10.5%

Purpose:

Cooling Pain Relief

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2016

Warnings

For external use only.

Flammable:

Keep away from excessive heat or open flame.

Contents Under Pressure. Do Not Punture Or Incinerate Do Not Store At Temperature Above 120°F

Ask a Doctor Before using If You have:

■ you experience pain, swelling or blistering of the skin
■ condition worsens, or if symptoms persist for more
than 7 days or clear up and occur again within a few
days
■ arthritic pain persists for more than 10 days, or
redness is present

When Using This Product

Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniments; Do not apply to irritated skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in a cool dry place

Stop Use And Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If pregnant or breast-feeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2016

Directions:

**Adults and children 12 years of age and older:**Spray on to the affected areas not more than 4 times daily; massage not necessary
**Children under 12 years of age:**Consult physician

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2016

Inactive Ingredients

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis
Flower Oil, Camellia Sinensis Leaf Oil, Chamomilla Recutita
(Matricaria) Flower Extract, Denatonium Benzoate, Echinacea
Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract,
Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis
Fruit Extract, Methylsulfonylmethane, Purified Water,
Tert-Butyl Alcohol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/19/2016

Questions or Comments:

1-800-246-3733

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Biofreeze - FDA Drug Approval Details