Label: BODYANEW MULTIPACK- bodyanew kit

  • 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 15, 2014

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

  • ACTIVE INGREDIENTS

    BodyAnew Rejuveo:

    Each 10 drops contain: *Bryonia alba 3X, *Bryonia alba 5X, *Bryonia alba 9X, *Bryonia alba 15X, *Bryonia alba 29X, *Bryonia alba 200X, *Bryonia alba 1000X, *Chelidonium majus 3X, *Colocynthis 3X, *Colocynthis 9X, *Colocynthis 30X, *Colocynthis 200X, *Lycopodium clavatum 3X, *Lycopodium clavatum 9X, *Lycopodium clavatum 29X, *Lycopodium clavatum 200X, *Lycopodium clavatum 1000X, *Nux vomica 3X, *Nux vomica 10X, *Nux vomica 15X, *Nux vomica 30X, *Nux vomica 200X, *Nux vomica 1000X.

    *Natural Ingredients

    BodyAnew Purity:

    Each 10 drops contain: *Berberis vulgaris 3X, *Berberis vulgaris 10X, *Berberis vulgaris 10X, *Berberis vulgaris 200X, *Colocynthis 3X, *Colocynthis 6X, *Colocynthis 30X, *Colocynthis 200X, *Solidago virgaurea 3X, *Solidago virgaurea 10X, *Solidago virgaurea 30X, *Solidago virgaurea 200X *Veratrum album 3X, *Veratrum album 6X, *Veratrum album 30X, *Veratrum album 200X.

    *Natural Ingredients

    BodyAnew Fatigue:

    Each 10 drops contain: *Apis mellifica 6X, Calcarea phosphorica 12X, *Dulcamara 6X, *Equisetum hyemale 4X, Ferrum iodatum 12X, *Fumaria officinalis 4X, *Gentiana lutea 5X, *Geranium robertianum 4X, Kali iodatum 8X, *Nasturtium aquaticum 4X, Natrum sulphuricum 3X, *Pinus sylvestris 4X, *Sarsaparilla 6X, *Scrophularia nodosa 3X, *Sticta pulmonaria 5X,*Teucrium scorodonia 3X, *Veronica officinalis 3X.

    *Natural Ingredients

  • PURPOSE

    BodyAnew Rejuveo: Bloating, Nausea, Indigestion

    BodyAnew Purity: Urinary pain, Urinary burning

    BodyAnew Fatigue: To help restore mental alertness when experiencing fatigue.

  • KEEP OUT OF REACH OF CHILDREN

    BodyAnew Rejuveo:

    Keep out of reach of children.

    BodyAnew Purity:

    Keep out of reach of children.

    BodyAnew Fatigue:

    Keep out of reach of children.

  • INDICATIONS AND USAGE

    BodyAnew Rejuveo: For the temporary relief of minor:

    • Bloating
    • Nausea
    • Indigestion

    BodyAnew Purity: For the temporary relief of minor:

    • Urinary pain
    • Urinary burning

    BodyAnew Fatigue: To help restore mental alertness when experiencing fatigue.

  • WARNINGS

    BodyAnew Rejuveo:

    If pregnant or breast-feeding, ask a healthcare provider before use. Keep out of reach of children. If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to BodyAnew Rejuveo™ or any of its ingredients exists.

    BodyAnew Purity:

    If pregnant or breast-feeding, ask a healthcare provider before use. Keep out of reach of children. If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to BodyAnew Purity™ or any of its ingredients exists.

    BodyAnew Fatigue:

    If pregnant or breast-feeding, ask a healthcare provider before use. Keep out of reach of children.

    For occasional use only. Not a substitute for sleep. If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to BodyAnew Fatigue™ or any of its ingredients exists.

  • DIRECTIONS

    BodyAnew Rejuveo:

    At first sign of symptoms:Adults and children 12 years and older: 10 drops every 1/2 to 1 hour until symptoms lessen, then continue with

    standard dosage.  Do not exceed 120 drops in 24 hours.

    For children under 12 years, consult your health professional.

    Standard Dosage:Adults and children above 12 years and older: 30 drops perday, taking 10 drops every 4 to 6 hours.

    For children under 12 years: Consult your health professional.

    BodyAnew Purity

    At first sign of symptoms: Adults and children 12 years and older: 10 drops every ½ to 1 hour until symptoms lessen, then continue with

    standard dosage.  Do not exceed 120 drops in 24 hours.

    For children under 12 years: Consult your health professional.

    Standard Dosage: Adults and children 12 years and older: 30 drops per day, taking 10 drops every 4 to 6 hours.

    For children under 12 years: Consult your health professional.

    BodyAnew Fatigue:

    At first signs of symptoms: Adults and children 12 years and older: 10 drops every ½ to 1 hour until symptoms lessen, then continue with

    standard dosage. Do not exceed 120 drops in 24 hours.

    For children under 12 years: Consult your health professional.

    Standard Dosage: Adults and children 12 years and older: 30 drops per day, taking 10 drops every 4 to 6 hours.

    For children under 12 years: Consult your health professional.

  • INACTIVE INGREDIENTS

    BodyAnew Rejuveo: Ethanol, Purified water

    BodyAnew Purity: Ethanol, Purified water

    BodyAnew Fatigue: Ethanol, Purified water

  • PRINCIPAL DISPLAY PANEL

    BodyAnew Multipack.jpg

  • INGREDIENTS AND APPEARANCE
    BODYANEW MULTIPACK 
    bodyanew kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-2000
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-2000-41 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 50 mL
    Part 21 BOTTLE 50 mL
    Part 31 BOTTLE 50 mL
    Part 1 of 3
    BODYANEW REJUVEO 
    bryonia alba root, chelidonium majus, citrullus colocynthis fruit pulp, lycopodium clavatum spore, and strychnos nux-vomica seed liquid
    Product Information
    Item Code (Source)NDC:62795-2002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 50 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 50 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP3 [hp_X]  in 50 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE3 [hp_X]  in 50 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED3 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-2002-450 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/30/2014
    Part 2 of 3
    BODYANEW PURITY 
    berberis vulgaris root bark, citrullus colocynthis fruit pulp, solidago virgaurea flowering top, and veratrum album root liquid
    Product Information
    Item Code (Source)NDC:62795-2003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 50 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 50 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]  in 50 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT3 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-2003-450 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/30/2014
    Part 3 of 3
    BODYANEW FATIGUE 
    apis mellifera, tribasic calcium phosphate, solanum dulcamara top, equisetum hyemale, ferrous iodide, fumaria officinalis flowering top, gentiana lutea root, geranium robertianum, potassium iodide, nasturtium officinale, sodium sulfate, pinus sylvestris leafy twig, smilax regelii root, scrophularia nodosa, lobaria pulmonaria, teucrium scorodonia flowering top, and veronica officinalis flowering top liquid
    Product Information
    Item Code (Source)NDC:62795-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 50 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 50 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP6 [hp_X]  in 50 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE4 [hp_X]  in 50 mL
    FERROUS IODIDE (UNII: F5452U54PN) (FERROUS IODIDE - UNII:F5452U54PN) FERROUS IODIDE12 [hp_X]  in 50 mL
    FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL) FUMARIA OFFICINALIS FLOWERING TOP4 [hp_X]  in 50 mL
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT5 [hp_X]  in 50 mL
    GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL) (GERANIUM ROBERTIANUM - UNII:R5I1HK0UBL) GERANIUM ROBERTIANUM4 [hp_X]  in 50 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION8 [hp_X]  in 50 mL
    NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM AQUATICUM - UNII:YH89GMV676) NASTURTIUM OFFICINALE4 [hp_X]  in 50 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE3 [hp_X]  in 50 mL
    PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73) (PINUS SYLVESTRIS LEAFY TWIG - UNII:Q1RGP4UB73) PINUS SYLVESTRIS LEAFY TWIG4 [hp_X]  in 50 mL
    SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX REGELII ROOT6 [hp_X]  in 50 mL
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA3 [hp_X]  in 50 mL
    LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA5 [hp_X]  in 50 mL
    TEUCRIUM SCORODONIA FLOWERING TOP (UNII: LOK3I16O7G) (TEUCRIUM SCORODONIA FLOWERING TOP - UNII:LOK3I16O7G) TEUCRIUM SCORODONIA FLOWERING TOP3 [hp_X]  in 50 mL
    VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J) (VERONICA OFFICINALIS FLOWERING TOP - UNII:9IH82J936J) VERONICA OFFICINALIS FLOWERING TOP3 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-2001-450 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/30/2014
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-2002, 62795-2003, 62795-2001)