Label: FLEXITOL NATURALS ECZEMA AND PSORIASIS- sodium borate, graphite, potassium sulfate, and sodium chloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 20, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
    †
    The letters E & P R indicate Eczema & Psoriasis Relief.
    Borax (20 X H.P.U.S. 0.2%)*†E & P R
    Graphites (6 X H.P.U.S. 0.2%)*E & P R
    Kalium Sulphuricum (3 X H.P.U.S. 0.2%)*E & P R
    Natrum Muriaticum (12 X H.P.U.S. 0.2%)*E & P R
  • Uses

    • Use on affected areas for relief of itching, irritation, redness, flaking and scaling associated with Eczema & Psoriasis.
  • Warnings

    • For External Use Only
       
    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

    • Keep out of reach of children

    • If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician.
  • Directions

    • Apply to affected skin 2-3 times daily
    • Smooth in gently
    • The smallest effective dose should be used
    • Patch test recommended on sensitive skin
    • For best results use together with FLEXITOL NATURALS Eczema & Psoriasis Wash.
  • Other information

    • Store between 50°- 86°F in a dry place
  • Inactive ingredients

    Water, Cetearyl Alcohol, Paraffin, Zinc Oxide, Paraffin Oil, Lavender Oil, Ceteareth-20, Licorice (Glycyrrhiza Glabra) Extract, Avocado Oil, Chamomile Oil, Diazolidinyl Urea, Phenoxyethanol, Evening Primrose Oil, Tocopheryl Acetate, Aloe Vera Gel

  • Questions or comments?

    Call Toll Free 1-866-478-3338
    usainfo@flexitol.com
    www.flexitol.com

  • PRINCIPAL DISPLAY PANEL - 56 g Carton

    NON
    STEROIDAL

    Flexitol
    NATURALS     ®

    Trust Flexitol . . .

    ECZEMA
    & PSORIASIS
    CREAM

    . . . it really works!

    Before
    After

    For the Relief of
    Skin Irritation, Itching,
    Flaking & Dryness

    Contains 0.2% Ethanol w/w

    Net Wt 2 oz (56 g)

    PRINCIPAL DISPLAY PANEL - 56 g Carton
  • INGREDIENTS AND APPEARANCE
    FLEXITOL NATURALS ECZEMA AND PSORIASIS 
    sodium borate, graphite, potassium sulfate, and sodium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-2231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Borate (UNII: 91MBZ8H3QO) (Sodium Cation - UNII:LYR4M0NH37) Sodium Borate20 [hp_X]  in 1 g
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite6 [hp_X]  in 1 g
    Potassium Sulfate (UNII: 1K573LC5TV) (Potassium Cation - UNII:295O53K152) Potassium Sulfate3 [hp_X]  in 1 g
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Lavandula Angustifolia Flower (UNII: 19AH1RAF4M)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    Glycyrrhiza Glabra (UNII: 2788Z9758H)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Shea Butter (UNII: K49155WL9Y)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Sorbic Acid (UNII: X045WJ989B)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Chamaemelum Nobile Flower Oil (UNII: UB27587839)  
    Evening Primrose Oil (UNII: 3Q9L08K71N)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43251-2231-11 in 1 CARTON
    156 g in 1 TUBE
    2NDC:43251-2231-21 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/03/2009
    Labeler - LaCorium Health International Pty Ltd (758651624)
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