Dosage and administration
Provides penetrating temporary relief for minor pain in muscles and joints associated with: Backache Arthritis Bruises Sprains
Joint and Muscle Pain
- Manufacturer
- BioZone Laboratories, Inc.
- Effective date
- 2010-07-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 22:25:22
Label at a glance#
ProductJoint and Muscle Pain
Active ingredientMenthol
Label structure7 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Menthol (5%)
OTC - PURPOSE SECTION
Topical Analgesic
Directions
Provides penetrating temporary relief for minor pain in muscles and joints associated with:
- Backache
- Arthritis
- Bruises
- Sprains
Warnings
- For external use only. Do not use with a heating pad. Do not apply to wounds or damaged skin. Do not bandage tightly after use.
- Avoid contact with eyes.
- Discontinue use and consult a physician if condition worsens, or if symptoms persist 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
- Adults and children over the age of 2: Apply generously to affected area. Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily.
- Children under the age of 2: Do not use; consult a physician.
Inactive Ingredients
Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Image: tube_shk10_1.jpg
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55379-404-85 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-db22-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55379-404-85 | Joint and Muscle Pain | 85 g in 1 TUBE | CREAM | 85 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Menthol | ACTIVE INGREDIENT | L7T10EIP3A | 6 | |
| Menthol | ACTIVE MOIETY | L7T10EIP3A | 6 |
Products#
Every source-derived product name is available through these pages.
- Joint and Muscle Pain
- Menthol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55379-404 | 55379-404-85 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Menthol | L7T10EIP3A | ACTIB |
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 |
|---|---|---|---|---|---|---|
| ac502553-75ab-458f-8130-9b6013c2004c | 8d0cb441-4cc9-4225-abd5-e034a6b834b8 | 2010-07-28 | Warnings | ac502553-75ab-458f-8130-9b6013c2004c 8d0cb441-4cc9-4225-abd5-e034a6b834b8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.