OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Menthol 2%...........................................External Analgesic
Active ingredient Purpose
Menthol 2%...........................................External Analgesic
Uses
For the temporary relief of minor aches and pains
of muscles and joints associated with simple backache,
arthritis, strains, bruises and sprains
Warnings
For external use only
When using this product • avoid
contact with eyes • do not bandage tightly • do not apply to
wounds or damaged skin • do not use with a heating pad
Stop use and ask doctor if condition worsens or if
symptoms persist for more than 7 days or clear up and
occur again within a few days
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away
Directions
• for adults & children 2 years of age and older
• cleanse and dry skin
• apply to affected area not more than 3 to 4 times daily
• children under 2 years of age, consult a doctor
Inactive ingredients
Ammonium Hydroxide,
Carbomer, Cupric Sulfate, FD&C Blue No. 1, Isopropyl
Alcohol, Magnesium Sulfate, Purified Water, Sodium
Hydroxide, Thymol.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-879-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-519a-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-879-06 | Therapeutic Ice | 227 g in 1 JAR | GEL | 227 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-879 | 36800-879-06 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Menthol | L7T10EIP3A | ACTIB |
| AMMONIA | 5138Q19F1X | IACT |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | IACT |
| Cupric Sulfate | LRX7AJ16DT | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| Isopropyl Alcohol | ND2M416302 | IACT |
| MAGNESIUM SULFATE, UNSPECIFIED FORM | DE08037SAB | IACT |
| WATER | 059QF0KO0R | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
| Thymol | 3J50XA376E | 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 |
|---|---|---|---|---|---|---|
| 85afb813-0ed8-44ea-a71b-5d7b5e350c0f | 596e5407-9271-4fcd-a0e6-e1af1b93916e | 2018-06-25 | Warnings | 85afb813-0ed8-44ea-a71b-5d7b5e350c0f 596e5407-9271-4fcd-a0e6-e1af1b93916e |
Adverse event summaries are temporarily unavailable. Other product information remains available.