Label: FLEX POWER CREAM- glycerin cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 4, 2014

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    water, isopropyl palmitate, butylene glycol, stearic acid, glyceryl stearate, cetyl alcohol, polysorbate 61, witch hazel ext, butylene glycol, pentylene glycol, petrolatum, peg-101 stearate, dimethicone, cetyl ethylhexanoate, vanillyl butyl ether, squalane, triethanolamine, carbomer, lactic acid, xanthan gum, dimethyl sulfone, acetyl glucosamine, paeonia suffruticosa root ext, scutellaria baicalensis root ext, cetyl pyridinium chloride, sodium dehydroacetate, hexylene glycol, beeswax, fragrance, disodium edta, tocopheryl acetate, hydrogenated lecithin, ceramide 4, tea-cocoyl glutamate, caprylic/capric triglyceride, cholesterol


  • PURPOSE

    endless effort to improve performance and passion for healthy lifestyle

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    massage on body for warming sensation
    use apply gradually to build comfort level for warming sensation


  • WARNINGS

    use only as directed
    avoid contact with eyes, face, wounds, damaged skin or sensitive areas. if contact occurs, flush with water for 15 minutes


  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    FLEX POWER CREAM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69093-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69093-1001-1100 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/03/2014
    Labeler - FLEX-POWER KOREA INC (688413457)
    Registrant - FLEX-POWER KOREA INC (688413457)
    Establishment
    NameAddressID/FEIBusiness Operations
    FLEX-POWER KOREA INC688413457manufacture(69093-1001)
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