DRAINER - benzoic acidum, berberis vulg., bryonia, cantharis,carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom., ptelea, taraxacum, uricum acidum, carduus mar., cynara scolymus, solidago, taraxacum liquid 
Newton Laboratories, Inc.

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.

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Drainer

PRODUCT NAME & INDICATIONS SECTION

Drainer  Formulated for liver, kidney and colon functions and for symptoms associated with toxic conditions.   

DIRECTION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) at bedtime or as directed by a healthcare professional. 

ACTIVE INGREDIENT SECTION

Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Carduus benedictus 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Dioscorea 15x, Dolichos 15x, Iris versicolor 15x, Juniperus com.15x, Nux vom. 15x, Ptelea 15x, Taraxacum 15x, Uricum acidum 15x,Carduus mar. 3x, Cynara scolymus 3x,  Solidago 3x, Taraxacum 3x.              

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.       

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 -Conyers, GA 30012
Questions?  1.800.448.7256  

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.       

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.           

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.     

PACKAGE LABEL

Package Label
DRAINER  
benzoic acidum, berberis vulg., bryonia, cantharis,carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom., ptelea, taraxacum, uricum acidum, carduus mar., cynara scolymus, solidago, taraxacum liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4400
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM) Benzoic Acid15 [hp_X]  in 1 mL
Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 mL
Cnicus Benedictus (UNII: 6L5ZL09795) (Cnicus Benedictus - UNII:6L5ZL09795) Cnicus Benedictus15 [hp_X]  in 1 mL
Ceanothus Americanus Leaf (UNII: 25B1Y14T8N) (Ceanothus Americanus Leaf - UNII:25B1Y14T8N) Ceanothus Americanus Leaf15 [hp_X]  in 1 mL
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
Chionanthus Virginicus Bark (UNII: S9Y4B22U2E) (Chionanthus Virginicus Bark - UNII:S9Y4B22U2E) Chionanthus Virginicus Bark15 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
Dioscorea Villosa Tuber (UNII: IWY3IWX2G8) (Dioscorea Villosa Tuber - UNII:IWY3IWX2G8) Dioscorea Villosa Tuber15 [hp_X]  in 1 mL
Mucuna Pruriens Fruit Trichome (UNII: 3E271BSI0C) (Mucuna Pruriens Fruit Trichome - UNII:3E271BSI0C) Mucuna Pruriens Fruit Trichome15 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root15 [hp_X]  in 1 mL
Juniper (UNII: 464910T5N9) (Juniper - UNII:464910T5N9) Juniper15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Ptelea Trifoliata Bark (UNII: 5KQR6FTT0D) (Ptelea Trifoliata Bark - UNII:5KQR6FTT0D) Ptelea Trifoliata Bark15 [hp_X]  in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale15 [hp_X]  in 1 mL
Uric Acid (UNII: 268B43MJ25) (Uric Acid - UNII:268B43MJ25) Uric Acid15 [hp_X]  in 1 mL
Silybum Marianum Seed (UNII: U946SH95EE) (Silybum Marianum Seed - UNII:U946SH95EE) Silybum Marianum Seed3 [hp_X]  in 1 mL
Cynara Scolymus Leaf (UNII: B71UA545DE) (Cynara Scolymus Leaf - UNII:B71UA545DE) Cynara Scolymus Leaf3 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4400-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4400-259.14 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE, API MANUFACTURE

Revised: 6/2011
Document Id: e821e739-51c3-3c48-421b-2c8230efefd6
Set id: 1944fe7b-8d1f-bde9-c67c-486dae25ba63
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.