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BODYANEW MULTIPACK (bodyanew) kit
[Heel Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved homeopathic
NOTE: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 Sections

ACTIVE INGREDIENTS

BodyAnew Rejuveo:

Each 50ml contains: Active Ingredients: Each 10 drops contain:*Bryonia alba 3X, 6X, 10X, 15X, 30X, 200X, 1000X, *Colocynthis 3X, 10X, 30X, 200X, *Lycopodium clavatum 3X, 10X, 30X, 200X, 1000X, *Nux vomica 3X, 10X, 15X, 30X, 200X, 1000X

BodyAnew Purity:

Each 50ml contains:Active Ingredients: Each 10 drops contain: *Berberis vulgaris 2X (Final Concentration 4X), 10X, 30X, 200X, *Colocynthis 3X, 10X, 30X, 200X, *Veratrum album 3X, 10X, 30X, 200X

BodyAnew Fatigue:

Each 50ml contains: Active Ingredients: Each 10 drops contain: *Aranea diadema 6X, Calcarea phosphorica 12X, *Equisetum hyemale 4X, Ferrum iodatum 12X, *Fumaria officinalis 4X, *Gentiana lutea 5X, *Geranium robertianum 4X, Levothyroxine 12X, *Myosotis arvensis 3X, Natrum sulphuricum 4X, *Nasturtium aquaticum 4X, *Pinus sylvestris 4X, *Sarsaparilla 6X, *Scrophularia nodosa 3X, *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.

DOSAGE AND ADMINISTRATION

BodyAnew Rejuveo:

Standard Dosage:

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

Children under 12 years: Consult your healthcare provider.

Initial Dosage:

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.

Children under 12 years: Consult your healthcare provider.

BodyAnew Purity:

Standard Dosage:

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

Children under 12 years: Consult your healthcare provider.

Initial Dosage:

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.

Children under 12 years: Consult your healthcare provider.

BodyAnew Fatigue:

Standard Dosage:

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

Children under 12 years: Consult your healthcare provider.

Initial Dosage:

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.

Children under 12 years: Consult your healthcare provider.

INACTIVE INGREDIENTS

BodyAnew Rejuveo: Ethanol, Purified water

BodyAnew Purity: Ethanol, Purified water

BodyAnew Fatigue: Ethanol, Purified water

BodyAnew Multipack.jpg

BODYANEW MULTIPACK 
bodyanew kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50114-8600
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8600-41 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, citrullus colocynthis fruit pulp, lycopodium clavatum spore and strychnos nux-vomica seed liquid
Product Information
Item Code (Source)NDC:50114-1500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT3 [hp_X]  in 50 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP3 [hp_X]  in 50 mL
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE3 [hp_X]  in 50 mL
STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED3 [hp_X]  in 50 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-1500-450 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/13/2013
Part 2 of 3
BODYANEW PURITY 
berberis vulgaris root bark, citrullus colocynthis fruit pulp and veratrum album root liquid
Product Information
Item Code (Source)NDC:50114-1522
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BERBERIS VULGARIS ROOT BARK (BERBERIS VULGARIS ROOT BARK) BERBERIS VULGARIS ROOT BARK2 [hp_X]  in 50 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP3 [hp_X]  in 50 mL
VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT3 [hp_X]  in 50 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-1522-450 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/13/2013
Part 3 of 3
BODYANEW FATIGUE 
araneus diadematus, tribasic calcium phosphate, equisetum hyemale, ferrous iodide, fumaria officinalis flowering top, gentiana lutea root, geranium robertianum, levothyroxine, myosotis arvensis, sodium sulfate, nasturtium officinale, pinus sylvestris leafy twig, smilax regelii root, scrophularia nodosa, teucrium scorodonia flowering top, and veronica officinalis flowering top liquid
Product Information
Item Code (Source)NDC:50114-1511
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARANEUS DIADEMATUS (ARANEUS DIADEMATUS) ARANEUS DIADEMATUS6 [hp_X]  in 50 mL
TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM CATION12 [hp_X]  in 50 mL
EQUISETUM HYEMALE (EQUISETUM HYEMALE) EQUISETUM HYEMALE4 [hp_X]  in 50 mL
FERROUS IODIDE (FERROUS IODIDE) FERROUS IODIDE12 [hp_X]  in 50 mL
FUMARIA OFFICINALIS FLOWERING TOP (FUMARIA OFFICINALIS FLOWERING TOP) FUMARIA OFFICINALIS FLOWERING TOP4 [hp_X]  in 50 mL
GENTIANA LUTEA ROOT (GENTIANA LUTEA ROOT) GENTIANA LUTEA ROOT5 [hp_X]  in 50 mL
GERANIUM ROBERTIANUM (GERANIUM ROBERTIANUM) GERANIUM ROBERTIANUM4 [hp_X]  in 50 mL
LEVOTHYROXINE (LEVOTHYROXINE) LEVOTHYROXINE12 [hp_X]  in 50 mL
MYOSOTIS ARVENSIS (MYOSOTIS ARVENSIS) MYOSOTIS ARVENSIS3 [hp_X]  in 50 mL
SODIUM SULFATE (SODIUM SULFATE ANHYDROUS) SODIUM SULFATE4 [hp_X]  in 50 mL
NASTURTIUM OFFICINALE (NASTURTIUM AQUATICUM) NASTURTIUM OFFICINALE4 [hp_X]  in 50 mL
PINUS SYLVESTRIS LEAFY TWIG (PINUS SYLVESTRIS LEAFY TWIG) PINUS SYLVESTRIS LEAFY TWIG4 [hp_X]  in 50 mL
SMILAX REGELII ROOT (SARSAPARILLA) SMILAX REGELII ROOT6 [hp_X]  in 50 mL
SCROPHULARIA NODOSA (SCROPHULARIA NODOSA) SCROPHULARIA NODOSA3 [hp_X]  in 50 mL
TEUCRIUM SCORODONIA FLOWERING TOP (TEUCRIUM SCORODONIA FLOWERING TOP) TEUCRIUM SCORODONIA FLOWERING TOP3 [hp_X]  in 50 mL
VERONICA OFFICINALIS FLOWERING TOP (VERONICA OFFICINALIS FLOWERING TOP) VERONICA OFFICINALIS FLOWERING TOP3 [hp_X]  in 50 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-1511-450 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/13/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/13/2013
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Heel Inc102783016manufacture(50114-1500, 50114-1522, 50114-1511)

Revised: 1/2014
 
Heel Inc

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