Flexin

Manufacturer
Whyteman Labs LLC
Effective date
2015-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:00

Label at a glance#

ProductFlexin
Active ingredientCAPSAICIN, MENTHOL
Label structure10 sections

Indications and uses

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.

Dosage and administration

Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily. Children under 12 years, consult a physician before use. How to apply: Clean and dry affected area. Cut open pouch and remove patch. Remove protective film and apply directly to area of pain. Apply to affected area not more than 3 times daily. Wash hands with soap after applying patch. Reseal pouch containing unused patc...

Storage and handling

Store below 25°C (77°F) Avoid direct sunlight.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.00%

OTC - PURPOSE SECTION

External Analgesic/Counterirritant

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.0375%

OTC - PURPOSE SECTION

External Analgesic

USES :

INDICATIONS & USAGE SECTION

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.

WARNINGS :

WARNINGS SECTION

  • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. Consult physician for use in children under 12.

OTC - DO NOT USE SECTION

  • Do not use if you are allergic to Menthol or Capsaicin.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occurs again within a few days, or if rash, itching or excessive skin irritation occurs.

DIRECTIONS :

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily.
  • Children under 12 years, consult a physician before use.
  • How to apply:
  • Clean and dry affected area.
  • Cut open pouch and remove patch. Remove protective film and apply directly to area of pain.
  • Apply to affected area not more than 3 times daily.
  • Wash hands with soap after applying patch.
  • Reseal pouch containing unused patches.

INACTIVE INGREDIENTS :

INACTIVE INGREDIENT SECTION

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80,

Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt,

Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcarbamate, Propylparaben.

STORAGE AND HANDLING SECTION

Store below 25°C (77°F)

Avoid direct sunlight.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flexin LabelFlexin Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchPSN2
1300889capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD2
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69695-1974-12020-01-31C16284748780-19d75b9cf-fbba-f424-e053-dadaa90a57ce1ac3e745-9fbe-0f7d-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69695-1974-1Flexin15 in 1 BOXPATCH152
69695-1974-1Flexin5 in 1 POUCHPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69695-1974FLEXIN (MENTHOL AND CAPSAICIN) PATCH [WHYTEMAN LABS LLC]2Legacy NDC, 2 package rows20151111_1ac3e745-9fbe-0f7d-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69695-1974-1EA - Each69695-1974068488da-45b1-4ee3-a813-4cefddc09ec312015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
CAPSAICINACTIVE MOIETYS07O44R1ZM2
MENTHOLACTIVE MOIETYL7T10EIP3A2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW42
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV02
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69695-197469695-1974-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 316 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SOFT TISSUE4 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER, FOR SUSPENSION / ORAL396 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
2448c701-124c-0634-e054-00144ff88e881ac3e745-9fbe-0f7d-e054-00144ff8d46c2015-11-11WarningsExact identifier
spl id: 2448c701-124c-0634-e054-00144ff88e88
spl set id: 1ac3e745-9fbe-0f7d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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