FlexaCure
- Manufacturer
- Symedic LLC
- Effective date
- 2019-10-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:00:48
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Menthol USP 2.25%
DOSAGE & ADMINISTRATION SECTION
Apply as needed.
WARNINGS SECTION
(for external use only)
OTC - WHEN USING SECTION
When using this product
• use only as directed
• do not bandage tightly or use with heating pad
• avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged skin
OTC - STOP USE SECTION
Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
INSTRUCTIONS FOR USE SECTION
adults and children 12 years of age and older:
• apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
INACTIVE INGREDIENT SECTION
Arnica Montana Flower Extract, Chondroitin Sulfate, Dimethyl Sulfone USP (MSM), Dimethyl Sulfoxide USP (DMSO), Glucosamine HCL (Shellfish), Glycerin, Hydrogen Peroxide, Magnesium Chloride, Propylene Glycol, Water (Aqua)
OTHER SAFETY INFORMATION
Persons with a known allergy to shellfish or sulfur should not use this product
STATEMENT OF IDENTITY SECTION
INDICATIONS & USAGE SECTION
Uses: Temporarily relieves minor pain associated with:
• arthritis • simple backache • muscle strains
• sprains • bruises • cramps
OTC - PURPOSE SECTION
Topical Analgesic
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71402-007-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3417-a910-e053-dadaa90a0b85 | 94e7337b-c58f-bf64-e053-2a95a90a1dbf |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71402-007-01 | FlexaCure | 29 mL in 1 BOTTLE, SPRAY | SPRAY | 29 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- FlexaCure
- menthol
- ARNICA MONTANA FLOWER
- DIMETHYL SULFOXIDE
- GLYCERIN
- MAGNESIUM CHLORIDE
- PROPYLENE GLYCOL
- HYDROGEN PEROXIDE
- CHONDROITIN SULFATE (BOVINE)
- CONDOLIASE
- DIMETHYL SULFATE
- GLUCOSAMINE HYDROCHLORIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71402-007 | 71402-007-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ARNICA MONTANA FLOWER | OZ0E5Y15PZ | IACT |
| DIMETHYL SULFOXIDE | YOW8V9698H | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MAGNESIUM CHLORIDE | 02F3473H9O | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| CHONDROITIN SULFATE (BOVINE) | 6IC1M3OG5Z | IACT |
| DIMETHYL SULFATE | JW5CW40Z50 | IACT |
| GLUCOSAMINE HYDROCHLORIDE | 750W5330FY | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| 94e7337b-c590-bf64-e053-2a95a90a1dbf | 94e7337b-c58f-bf64-e053-2a95a90a1dbf | 2019-10-14 | Warnings | 94e7337b-c590-bf64-e053-2a95a90a1dbf 94e7337b-c58f-bf64-e053-2a95a90a1dbf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
