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#

ProductFlexaCure
Active ingredientMENTHOL
Label structure10 sections

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

Dist. by: Symedic LLC Las Vegas, NV 89147

MADE IN USA ©2019 FlexaCure

www.flexacure.com

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

Active IngredientsActive Ingredients

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2205491menthol 2.25 % Topical SprayPSN4
2205491menthol 22.5 MG/ML Topical SpraySCD4
2205491menthol 2.25 % Topical SpraySY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71402-007-012021-01-29C16284748780-1ba0f9c33-3417-a910-e053-dadaa90a0b8594e7337b-c58f-bf64-e053-2a95a90a1dbf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71402-007-01FlexaCure29 mL in 1 BOTTLE, SPRAYSPRAY294

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71402-007FLEXACURE (MENTHOL) SPRAY [SYMEDIC LLC]4Legacy NDC, 1 package rows20191015_94e7337b-c58f-bf64-e053-2a95a90a1dbf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71402-00771402-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
94e7337b-c590-bf64-e053-2a95a90a1dbf94e7337b-c58f-bf64-e053-2a95a90a1dbf2019-10-14WarningsExact identifier
spl id: 94e7337b-c590-bf64-e053-2a95a90a1dbf
spl set id: 94e7337b-c58f-bf64-e053-2a95a90a1dbf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.