Indications and uses
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains
Biofreeze Spray
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2026-05-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- full-release
- Hydrated at
- 2026-06-01 01:57:37
Label at a glance#
ProductBiofreeze
Active ingredientMENTHOL
Label structure7 sections
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients:
Menthol 10.5%
Purpose:
Cooling Pain Relief
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains
Warnings
For external use only.
Flammable:
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:
■ 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
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 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
Questions or Comments:
1-800-246-3733
Package Labeling:
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1489074 | BIOFREEZE 10.5 % Topical Spray | PSN | 12 |
| 1489073 | menthol 10.5 % Topical Spray | PSN | 12 |
| 1489074 | menthol 105 MG/ML Topical Spray [Biofreeze] | SBD | 12 |
| 1489073 | menthol 105 MG/ML Topical Spray | SCD | 12 |
| 1489074 | Biofreeze 10.5 % Topical Spray | SY | 12 |
| 1489074 | Biofreeze 105 MG/ML Topical Spray | SY | 12 |
| 1489073 | menthol 10.5 % Topical Spray | SY | 12 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0731124000071 | GTIN-13: 0731124000071 EAN-13: 0731124000071 GTIN-12: 731124000071 UPC-A: 731124000071 GTIN storage (14 digits): 00731124000071 | BF spray updated AW 3.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59316-833-10 | Biofreeze | 89 mL in 1 BOTTLE | SPRAY | 89 | 12 | |
| 59316-833-20 | Biofreeze | 118 mL in 1 BOTTLE | SPRAY | 118 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59316-833-10 | ML - Milliliter | 59316-833 | a7b60bb1-2302-473f-8bae-ed1aaafc2b73 | 1 | 2024-03-12 |
Products#
Every source-derived product name is available through these pages.
- Biofreeze
- MENTHOL
- ISOPROPYL ALCOHOL
- DENATONIUM BENZOATE
- TERT-BUTYL ALCOHOL
- ARNICA MONTANA FLOWER
- CALENDULA OFFICINALIS FLOWER
- CHAMOMILE
- DIMETHYL SULFONE
- ALCOHOL
- ILEX PARAGUARIENSIS LEAF
- ISOPROPYL MYRISTATE
- JUNIPER BERRY
- WATER
- ECHINACEA ANGUSTIFOLIA WHOLE
- TEA LEAF OIL
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59316-833 | 59316-833-10, 59316-833-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Biofreeze | MENTHOL | Reckitt Benckiser LLC | 00bb462a-27d0-6f74-e063-6394a90a90ec | 2026-05-13 | Warnings | 59316-833-10 59316-833-20 59316-833 59316083310 59316083320 51b57ded-2d7c-d540-e063-6394a90a4744 00bb462a-27d0-6f74-e063-6394a90a90ec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.