Dosage and administration
Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor.
X-Treme Freeze
- Manufacturer
- Dynarex Corporation
- Effective date
- 2026-01-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:34:29
Label at a glance#
ProductX-Treme Freeze
Active ingredientMENTHOL
Label structure12 sections
Storage and handling
• Store in a cool dry place • Tamper evident. Do not use if seal is damaged.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Menthol USP 4% Active
Purpose
Cooling Pain Relief
Use(s)
• Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains
• Provides penetrating pain relief
Warnings
For External Use Only
When using this product
• Avoid contact with eyes
• Do not apply to wounds or damaged skin
• Do not bandage tightly
Stop use and ask a doctor if:
• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days, discontinue use of this product
If pregnant or breast feeding:
Ask a health professional before use.
Keep out of reach of children
If swallowed, get medical help. Contact a physician or Poison Control Center (1-800-222-1222) right way.
Directions
- Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: Do not use, consult a doctor.
Other Information
• Store in a cool dry place
• Tamper evident. Do not use if seal is damaged.
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Certerii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leaf), Camphor, Carbomer, Glycerin, Llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, Tocopheryl Acetate, Triethanolamine
Questions?
1-888-DYNAREX Monday-Friday, 9AM-5PM EST
1441 Label
1442 Label
1444 Label
1447 Label
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0616784144122 | GTIN-13: 0616784144122 EAN-13: 0616784144122 GTIN-12: 616784144122 UPC-A: 616784144122 GTIN storage (14 digits): 00616784144122 | 1441_BX_MASTER_250929-4.jpg |
| Barcode | EAN-13 | 0616784144214 | GTIN-13: 0616784144214 EAN-13: 0616784144214 GTIN-12: 616784144214 UPC-A: 616784144214 GTIN storage (14 digits): 00616784144214 | 1442_IN_MASTER_R250929-4.jpg |
| Barcode | EAN-13 | 0616784144412 | GTIN-13: 0616784144412 EAN-13: 0616784144412 GTIN-12: 616784144412 UPC-A: 616784144412 GTIN storage (14 digits): 00616784144412 | 1444_IN_MASTER_R221220-1.jpg |
| Barcode | EAN-13 | 0616784144719 | GTIN-13: 0616784144719 EAN-13: 0616784144719 GTIN-12: 616784144719 UPC-A: 616784144719 GTIN storage (14 digits): 00616784144719 | 1447_IN MASTER_R221220-1.jpg |
| QR code link | QR Code |  dynarex.com/symbols.php | 1447_IN MASTER_R221220-1.jpg, 1444_IN_MASTER_R221220-1.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67777-144-10 | X-Treme Freeze | 200 in 1 CASE | GEL | 200 | 6 | |
| 67777-144-11 | X-Treme Freeze | 3 mL in 1 PACKET | GEL | 3 | 6 | |
| 67777-144-11 | X-Treme Freeze | 100 in 1 BOX | GEL | 100 | 6 | |
| 67777-144-20 | X-Treme Freeze | 24 in 1 CASE | GEL | 24 | 6 | |
| 67777-144-21 | X-Treme Freeze | 118 mL in 1 TUBE | GEL | 118 | 6 | |
| 67777-144-40 | X-Treme Freeze | 12 in 1 CASE | GEL | 12 | 6 | |
| 67777-144-41 | X-Treme Freeze | 473 mL in 1 BOTTLE, PUMP | GEL | 473 | 6 | |
| 67777-144-70 | X-Treme Freeze | 2 in 1 CASE | GEL | 2 | 6 | |
| 67777-144-71 | X-Treme Freeze | 3785 mL in 1 BOTTLE, PLASTIC | GEL | 3785 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67777-144-20 | ML - Milliliter | 67777-144 | c5e5bb15-c596-4135-9b13-a9e2bb6d3450 | 1 | 2023-02-06 |
| 67777-144-21 | ML - Milliliter | 67777-144 | c85e8f2f-7945-46bc-972d-dd9147d19cad | 1 | 2023-02-06 |
Products#
Every source-derived product name is available through these pages.
- X-Treme Freeze
- Cold Therapy Gel
- ISOPROPYL MYRISTATE
- TROLAMINE
- MENTHOL
- CARBOXYPOLYMETHYLENE
- ALOE VERA LEAF
- GLYCERIN
- ISOPROPYL ALCOHOL
- ARNICA MONTANA FLOWER
- FRANKINCENSE
- CALENDULA OFFICINALIS FLOWER
- ILEX PARAGUARIENSIS LEAF
- MELISSA OFFICINALIS LEAF
- ARCTIUM LAPPA ROOT
- GREEN TEA LEAF
- ALPHA-TOCOPHEROL ACETATE
- SILICON DIOXIDE
- .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR
- FD&C YELLOW NO. 5
- WATER
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67777-144 | 67777-144-11, 67777-144-10, 67777-144-21, 67777-144-20, 67777-144-41, 67777-144-40, 67777-144-71, 67777-144-70 |
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 |
|---|---|---|---|---|---|---|
| X-Treme Freeze | COLD THERAPY GEL | Dynarex Corporation | 79f0802f-03ad-bf8f-e053-2991aa0ae4b5 | 2026-01-22 | Warnings | 67777-144-11 67777-144-40 67777-144-41 67777-144-20 67777-144-10 67777-144-21 67777-144-71 67777-144-70 67777-144 67777014411 67777014440 67777014421 67777014470 67777014410 67777014420 67777014441 67777014471 48fdd7f5-f062-0f63-e063-6294a90a452a 79f0802f-03ad-bf8f-e053-2991aa0ae4b5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.