Flexigen

Manufacturer
Derma Care Research Labs, LLC
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:17

Label at a glance#

ProductFlexigen
Active ingredientMENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

OTC - PURPOSE SECTION


Pain Relieving Cream

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

WARNINGS SECTION

For external use only. Do not use with other topical pain relievers, with heating pads or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Boswellia Carterii Oil, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrus Sinensis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglyerin, Glycerin, Glyceryl Stearate SE, Hydrolyzed Rice Protein, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 60, Sesamum Indicum (Sesame) Seed Oil, Stearyl Alcohol, Tocopherol, Water, Xanthan Gum.

PREGNANCY SECTION

If pregnant or breast-feeding, ask a health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416982menthol 1.25 % Topical CreamPSN2
416982menthol 12.5 MG/ML Topical CreamSCD2
416982menthol 1.25 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-371-01Flexigen5 mL in 1 BOTTLECREAM52
72839-371-03Flexigen95 mL in 1 BOTTLECREAM952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-371FLEXIGEN (MENTHOL 1.25%) CREAM [DERMA CARE RESEARCH LABS, LLC]2Current NDC, Legacy NDC, 2 package rows20240116_e9ae2682-59b4-e796-e053-2995a90af921.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-37172839-371-03, 72839-371-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
ndc (package): 72839-371-01
ndc (package): 72839-371-03
ndc (product): 72839-371
ndc11 (package): 72839037101
ndc11 (package): 72839037103
spl id: 0f0164f7-b392-1bfd-e063-6394a90a3ca0
spl set id: e9ae2682-59b4-e796-e053-2995a90af921

Reported adverse events (FAERS/openFDA)#

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