Indications and uses
Uses Temporary relief from minor aches and pains of sore muscles and joints associated with: ■arthritis ■backache ■strains■sprains
Uses Temporary relief from minor aches and pains of sore muscles and joints associated with: ■arthritis ■backache ■strains■sprains
Directions Adults and children 2 years of age and older: ■rub a thin film over affected area not more than 4 times daily, massage not necessary Children under 2 years of age: consult physician
Drug Facts
Menthol 4%
Topical analgesic
Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:
■arthritis ■backache ■strains■sprains
For external use only
Flammable: keep away from excessive heat or open flame
When using this product:
■ avoid contact with 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 a heating pad or device
Stop use and ask a doctor if: the condition worsens, if the symptoms last more than 7 days or clear up and reoccur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.
Directions
Adults and children 2 years of age and older:■rub a thin film over affected area not more than 4 times daily, massage not necessary Children under 2 years of age: consult physician
Inactive ingredients aloe barbadensis leaf juice, aminomethyl propanol,arctium lappa extract, arnica montana flower extract, Boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&Cyellow
no.5, FD&C blue no.1, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol,isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71101-050-01 | HealthWise Soothing Cold Therapy Gel | 88.7 mL in 1 BOTTLE | GEL | 88.7 | 2 | |
| 71101-050-01 | HealthWise Soothing Cold Therapy Gel | 1 in 1 BOX | GEL | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71101-050 | 71101-050-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PARAFFIN | I9O0E3H2ZE | IACT |
| CEDAR LEAF OIL | BJ169U4NLG | IACT |
| NUTMEG OIL | Z1CLM48948 | IACT |
| THYMOL | 3J50XA376E | IACT |
| TURPENTINE OIL | C5H0QJ6V7F | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
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 |
|---|---|---|---|---|---|---|
| HealthWise Soothing Cold Therapy Gel | MENTHOL 4% | Veridian Healthcare | 1f09ccdd-09d8-6a8d-e063-6394a90a184f | 2024-08-08 | Warnings | 71101-050-01 71101-050 71101005001 1f2ef992-1262-4b39-e063-6394a90a6dd9 1f09ccdd-09d8-6a8d-e063-6394a90a184f |
Adverse event summaries are temporarily unavailable. Other product information remains available.