Biofreeze Portable Dry Solid

Manufacturer
Performance Health LLC
Effective date
2021-01-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:54:41

Label at a glance#

ProductBiofreeze Portable Dry Solid
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

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

Dosage and administration

• Adults and Children 12 years of age and older:  Turn dial to raise product until a small portion of the stick is showing. Apply by rubbing back and forth to the affected area 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%

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 • sprains

Warnings:

WARNINGS SECTION

For external use only

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

Sensitive skin

When using this product:

OTC - WHEN USING SECTION

• Use only as directed • Avoid contact with 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 • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight

Stop use and ask a doctor if:

OTC - STOP USE SECTION

You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breastfeeding:

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: Turn dial to raise product until a small portion of the stick is showing. Apply by rubbing back and forth to the affected area not more than 4 times daily. Massage not necessary 
• Children under 12 years of age: Consult physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Coco-caprylate/Caprate, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Isopentyldiol, Wax, Paraffin, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Isostearate, Silica, Sodium Chloride, Sorbitan Isostearate, Water

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-246-3733

Package Labeling:59316-879-22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:59316-879-23

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2BoxBox

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-87959316-879-22, 59316-879-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
c440cb3f-71f2-6be8-e053-2995a90afc9beb9e1fb8-1430-4b80-a083-64e121c727e42021-06-08WarningsExact identifier
spl set id: eb9e1fb8-1430-4b80-a083-64e121c727e4

Reported adverse events (FAERS/openFDA)#

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