Label: OSMOFLEX- menthol cream

  • NDC Code(s): 67676-101-01, 67676-101-03, 67676-101-04
  • Packager: Sarati International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts Active Ingredient

    Menthol 1.30%

  • Purpose

    Topical Analgesic

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For External Use Only

  • Do not use

    • on wounds or damaged skin
    • with a heating pad
  • When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
    • use only as directed
  • Stop Use and Ask A Doctor

    • 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

    Keep out of reach of children.

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

  • Directions

    • 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

    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

    Call 1-866-984-3054

  • Other 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

    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 1

    Sarati OsmoFlex 2

    res

  • INGREDIENTS AND APPEARANCE
    OSMOFLEX 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67676-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLAMIDE (UNII: 20R035KLCI)  
    TRICAPRYLIN (UNII: 6P92858988)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    WATER (UNII: 059QF0KO0R)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67676-101-01113.4 g in 1 TUBE; Type 0: Not a Combination Product05/16/2016
    2NDC:67676-101-04453.6 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/2016
    3NDC:67676-101-03964.3 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/16/2016
    Labeler - Sarati International, Inc. (160219770)
    Registrant - Sarati International, Inc. (160219770)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sarati International, Inc.160219770manufacture(67676-101)