Label: STALEAN- l-carnitine tartrate, l-isoleucine, l-leucine, l-valine, magnesia phosphorica, pyridoxine, spray

  • 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 July 13, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:  L Carnitine Tartrate 30X, 60X, L Isoleucine 30X, 60X, L Leucine 30X, 60X, L Valine 30X, 60X, Magnesia Phosphorica 30X, 60X, Pyridoxine 30X, 60X, Argentum Metallicum 60X, 100X, 200X, Calcarea Carbonica 60X, 100X, 200X, Mercurius Solubilis 60X, 100X, 200X, Natrum Sulphuricum 60X, 100X, 200X, Oleander 60X, 100X, 200X, Sabadilla 60X, 100X, 200X, Hypothalamus 6C, 12C, 30C, 100C, Dopamine 6C, 60C, 100C, 200C, Pancreas 6C, 60C, 100C, 200C, Serotonin 6C. 60C, 100C, 200C, Spleen 6C, 60C, 100C, 200C.

  • PURPOSE

    Indications:  Supports weight loss, insulin resistance, food cravings and emotional eating.  Provides support before, during and after dieting.

    Other helpful remedy; HCG Max


  • WARNINGS

    WARNINGS:  As with any drug,if pregnant or breast-feeding; or under age 18;  consult a physician before use.   Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.  Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

    Store in a cool, dry place after opening.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:   Adults Only;  1 or 2 sprays daily under the tongue as needed or as directed by a health professional.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Demineralized Water, 25% Ethanol, Cerato, Chestnut Bud, Gorse, Larch, Walnut, Wild Oat.

  • QUESTIONS

    Formulated and Dist. by:

    Weight Loss Products, LLC

    St. Petersburg, FL 33707

    www.STA-LEAN.com

    1-202-239-2130

  • PRINCIPAL DISPLAY PANEL

    SUPPORTS LONG TERM WEIGHT LOSS

    STA.LEAN

    ORAL SPRAY

    1 FL OZ / 30 ML

    HOMEOPATHIC FORMULA

    StaLean

  • INGREDIENTS AND APPEARANCE
    STALEAN 
    l-carnitine tartrate, l-isoleucine, l-leucine, l-valine, magnesia phosphorica, pyridoxine, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0190
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE60 [hp_X]  in 1 mL
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE60 [hp_X]  in 1 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER200 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE200 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS200 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SULFATE200 [hp_X]  in 1 mL
    NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6) NERIUM OLEANDER LEAF200 [hp_X]  in 1 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED200 [hp_X]  in 1 mL
    SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS100 [hp_C]  in 1 mL
    DOPAMINE (UNII: VTD58H1Z2X) (DOPAMINE - UNII:VTD58H1Z2X) DOPAMINE200 [hp_C]  in 1 mL
    SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS200 [hp_C]  in 1 mL
    SEROTONIN (UNII: 333DO1RDJY) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN200 [hp_C]  in 1 mL
    SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN200 [hp_C]  in 1 mL
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE60 [hp_X]  in 1 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE60 [hp_X]  in 1 mL
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE60 [hp_X]  in 1 mL
    LEVOCARNITINE TARTRATE (UNII: 4D8F2Q45LQ) (LEVOCARNITINE - UNII:0G389FZZ9M) LEVOCARNITINE TARTRATE60 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    AVENA SATIVA POLLEN (UNII: A7IKY24TR7)  
    CERATOSTIGMA WILLMOTTIANUM FLOWER (UNII: TP69J995TW)  
    LARIX DECIDUA FLOWERING TOP (UNII: 9UMZ642257)  
    JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG)  
    ULEX EUROPAEUS (UNII: 398DBS1PXN)  
    AESCULUS CARNEA FLOWER (UNII: 717DPT98VM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0190-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/12/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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