FDA.reportPublic FDA data

Biofreeze Spray

Manufacturer
Performance Health LLC
Effective date
2019-06-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:20:51

Label at a glance#

ProductBiofreeze
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.5%

Purpose:

OTC - PURPOSE SECTION

Cooling Pain Relief

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame.

SPL UNCLASSIFIED SECTION

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

Ask a Doctor Before using If You have:

OTC - ASK DOCTOR SECTION

Sensitive skin

When Using This Product

OTC - WHEN USING SECTION

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:

OTC - STOP USE SECTION

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

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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 Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-246-3733

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

89mL Label89mL Label473mL Label473mL Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-114-10ML - Milliliter59316-11434d03209-6552-449d-85d4-80c70328794812018-09-05
59316-114-25ML - Milliliter59316-114cf2515ba-bce7-4676-bd56-90f07f8450f712024-08-12
59316-114-30ML - Milliliter59316-11418baaf7f-09d9-4346-8fb2-3dbcf47bf5a112024-08-12

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
59316-11459316-114-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXIACT
ALCOHOL3K9958V90MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
JUNIPERUS COMMUNIS WHOLE464910T5N9IACT
BERRYFV3431923ZIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
ndc (package): 59316-114-10
ndc (product): 59316-114
ndc11 (package): 59316011410
8b9a94a8-ac47-f914-e053-2a95a90a6820bceb0d38-bb4f-4048-bfea-06a508e062552019-06-18WarningsExact identifier
spl id: 8b9a94a8-ac47-f914-e053-2a95a90a6820
spl set id: bceb0d38-bb4f-4048-bfea-06a508e06255

Reported adverse events (FAERS/openFDA)#

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