Indications and uses
temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries
temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries
Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.
Menthol 1.0%
Topical Analgesic
FOR EXTERNAL USE ONLY
Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.
If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.
In case of accidental ingestion, get medical help or contact a Poison Control Center right away
Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.
Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52410-0201-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3099-a910-e053-dadaa90a0b85 | 35d523ac-85df-3a92-e054-00144ff8d46c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52410-0201-2 | Cool Hot Ice Analgesic Gel | 227 g in 1 JAR | GEL | 227 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52410-0201 | COOL HOT ICE ANALGESIC GEL (MENTHOL) GEL [SHIELD LINE LLC] | 2 | Legacy NDC, 1 package rows | 20190525_35d523ac-85df-3a92-e054-00144ff8d46c.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52410-0201 | 52410-0201-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| NONOXYNOL-10 | K7O76887AP | IACT |
| CAMPHOR (SYNTHETIC) | 5TJD82A1ET | IACT |
| CARBOMER 934 | Z135WT9208 | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| METHYLCHLOROISOTHIAZOLINONE | DEL7T5QRPN | IACT |
| METHYLISOTHIAZOLINONE | 229D0E1QFA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| 89a5a583-e8a5-5ae6-e053-2a95a90aa348 | 35d523ac-85df-3a92-e054-00144ff8d46c | 2019-05-24 | Warnings | 89a5a583-e8a5-5ae6-e053-2a95a90aa348 35d523ac-85df-3a92-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.