FDA.reportPublic FDA data

OsmoFlex

Manufacturer
Sarati International, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:58:37

Label at a glance#

ProductOsmoFlex
Active ingredientMENTHOL
Label structure13 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily children under 12 years of age, ask a doctor massage a generous amount to affected area until absorbed.

Label contents#

Full prescribing information#

Drug Facts Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.30%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
  • use only as directed

Stop Use and Ask A Doctor

OTC - STOP USE SECTION

  • if conditions worsen or if symptoms persist for more that 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation.

If pregnant or breast feedingconsult a doctor before use.

Keep out of reach of children

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age, ask a doctor
  • massage a generous amount to affected area until absorbed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylamide/sodium acryloyldimethyl taurate copolymer, caprylic/capric triglyceride, caprylyl glycol, cetyl alcohol, chondroitin sulfate, deionized water, glucosamine sulfate, glycerin, glycerol stearate, isohexadecane, lecithin, magnesium sulfate heptahydrate (epsom salt), methylsulfonylmethane (msm), peg-100, stearate, phenoxyethanol, polyacrylate 13, polyisobutene, polysorbate 20, polysorbate 80, sd alcohol, shea butter, sorbic acid, stearic acid, xanthan gum

Questions

OTC - QUESTIONS SECTION

Call 1-866-984-3054

Other Information

OTHER SAFETY INFORMATION

  • each gram contains magnesium 6.6 mg
  • store and use at room temperature 20°-25° C (68°-77° F)
  • tamper resistant-do not use if seal under cap is broken or missing.

OsmoFlex product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OsmoFlex ™

Pain Relieving Cream Menthol 1.3%

Net Wt 4 oz (113.4g)

NET WT 16 OZ (453.6 g)

NET WT 32 OZ (964.3 g)

Dist. by: Seablue Vitamins, LLC • 211 North Locksley Drive • Lafayette, LA 70508

www.seabluevitamins.com

Sarati OsmoFlex 1Sarati OsmoFlex 1

Sarati OsmoFlex 2Sarati OsmoFlex 2

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
436147menthol 1.3 % Topical CreamPSN7
1050947Osmoflex 1.3 % Topical CreamPSN7
1050947menthol 13 MG/ML Topical Cream [Osmoflex]SBD7
436147menthol 13 MG/ML Topical CreamSCD7
436147menthol 1.3 % Topical CreamSY7
1050947Osmoflex 1.3 % Topical CreamSY7
1050947Osmoflex 13 MG/ML Topical CreamSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67676-101-01OsmoFlex113.4 g in 1 TUBECREAM113.47
67676-101-03OsmoFlex964.3 g in 1 BOTTLECREAM964.37
67676-101-04OsmoFlex453.6 g in 1 BOTTLECREAM453.67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67676-101OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]7Current NDC, Legacy NDC, 3 package rows20231102_479147c0-4cf4-4d7a-8b8e-1a0de49ed73e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
ACRYLAMIDEINACTIVE INGREDIENT20R035KLCI1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5Z1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT1
GLUCOSAMINE SULFATEINACTIVE INGREDIENT1FW7WLR7311
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A0651
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
MAGNESIUM SULFATE HEPTAHYDRATEINACTIVE INGREDIENTSK47B8698T1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYISOBUTYLENE (1200000 MW)INACTIVE INGREDIENTFLT10CH37X1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999R1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TRICAPRYLININACTIVE INGREDIENT6P928589881
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67676-10167676-101-01, 67676-101-04, 67676-101-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLAMIDE20R035KLCIIACT
TRICAPRYLIN6P92858988IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
WATER059QF0KO0RIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
ISOHEXADECANE918X1OUF1EIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYOXYL 100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYISOBUTYLENE (1200000 MW)FLT10CH37XIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
ALCOHOL3K9958V90MIACT
SHEA BUTTERK49155WL9YIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
MENTHOLL7T10EIP3AACTIB

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 2 · 100 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
44 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
44 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
44 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
44 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii+route
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYOXYL 100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TRICAPRYLINTRICAPRILIN6P92858988INJECTABLE, LIPOSOMAL / INFILTRATION0.2 %w/vExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
44 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
44 equally ranked IID candidates
TRICAPRYLINTRICAPRILIN6P92858988INJECTABLE, LIPOSOMAL / INFILTRATION0.2 %w/vExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
44 equally ranked IID candidates
TRICAPRYLINTRICAPRILIN6P92858988INJECTABLE, LIPOSOMAL / INFILTRATION0.2 %w/vExact identifier — unii candidate
8 equally ranked IID candidates
HYDROGENATED SOYBEAN LECITHINHYDROGENATED SOYBEAN LECITHINH1109Z9J4NCREAM / TOPICAL1.5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TRICAPRYLINTRICAPRILIN6P92858988INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL1 mgExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
44 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
44 equally ranked IID candidates
TRICAPRYLINTRICAPRILIN6P92858988INJECTABLE, LIPOSOMAL / INFILTRATION0.2 %w/vExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
44 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii+route
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
44 equally ranked IID candidates
POLYOXYL 100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYOXYL 100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYISOBUTYLENE (1200000 MW)POLYISOBUTYLENE (1100000 MW)FLT10CH37XSYSTEM / TOPICAL67 mgExact identifier — unii+route
4 equally ranked IID candidates
POLYISOBUTYLENE (1200000 MW)POLYISOBUTYLENE (1100000 MW)FLT10CH37XSYSTEM / TOPICAL67 mgExact identifier — unii+route
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
44 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
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
ndc (package): 67676-101-01
ndc (package): 67676-101-04
ndc (package): 67676-101-03
ndc (product): 67676-101
ndc11 (package): 67676010101
ndc11 (package): 67676010104
ndc11 (package): 67676010103
spl id: 08b4632c-2421-6046-e063-6294a90a1527
spl set id: 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e

Reported adverse events (FAERS/openFDA)#

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