Biofreeze
Biofreeze Spray
00bb462a-27d0-6f74-e063-6394a90a90ec
HUMAN OTC DRUG LABEL
Sep 2, 2025
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
Product Classification
Product Specifications
INGREDIENTS (16)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Labeling:
INDICATIONS & USAGE SECTION
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Menthol 10.5%
Purpose:
Cooling Pain Relief
WARNINGS SECTION
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
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
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
Questions or Comments:
1-800-246-3733