Detoxifier by Newton Laboratories, Inc. Detox 2418L-Dis

Detoxifier by

Drug Labeling and Warnings

Detoxifier by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DETOXIFIER- uricum acidum, benzoicum acidum, berber. vulg., bryonia, cantharis, carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom.,ptelea,taraxacum, 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.

----------

Detox 2418L-Dis

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) at bedtime or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Cynara 6x, Solidago 6x, Taraxacum 6x, Benzoicum acidum 10x, Berber. vulg. 10x, Bryonia 10x, Cantharis 10x, Carduus benedictus 10x, Carduus mar. 10x, Ceanothus 10x, Chelidonium majus 10x, Chionanthus virginica 10x, Cinchona 10x, Dioscorea 10x, Dolichos 10x, Iris versicolor 10x, Juniperus com. 10x, Ptelea 10x, Taraxacum 10x, Nux vom. 15x, Uricum ac 15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

INACTIVE INGREDIENT SECTION

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

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

DETOXIFIER 
uricum acidum, benzoicum acidum, berber. vulg., bryonia, cantharis, carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom.,ptelea,taraxacum, carduus mar., cynara scolymus, solidago,taraxacum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2418
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
URIC ACID (UNII: 268B43MJ25) (URIC ACID - UNII:268B43MJ25)	URIC ACID	15 [hp_X]  in 1 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	10 [hp_X]  in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	10 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	10 [hp_X]  in 1 mL
CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795)	CENTAUREA BENEDICTA	10 [hp_X]  in 1 mL
CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N)	CEANOTHUS AMERICANUS LEAF	10 [hp_X]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	10 [hp_X]  in 1 mL
CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E)	CHIONANTHUS VIRGINICUS BARK	10 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X]  in 1 mL
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA TUBER	10 [hp_X]  in 1 mL
MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C)	MUCUNA PRURIENS FRUIT TRICHOME	10 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	10 [hp_X]  in 1 mL
JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL)	JUNIPER BERRY	10 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X]  in 1 mL
PTELEA TRIFOLIATA BARK (UNII: 5KQR6FTT0D) (PTELEA TRIFOLIATA BARK - UNII:5KQR6FTT0D)	PTELEA TRIFOLIATA BARK	10 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	10 [hp_X]  in 1 mL
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	6 [hp_X]  in 1 mL
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE)	CYNARA SCOLYMUS LEAF	6 [hp_X]  in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-2418-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/31/2019	12/02/2019
2	NDC: 55714-2418-2	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/31/2019	12/02/2019
3	NDC: 55714-2418-0	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/31/2019	12/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/31/2019	12/02/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-2418)

Revised: 12/2019

Document Id: 9af037cf-4679-01b2-e053-2995a90a8abe

34390-5

Set id: 91352535-deed-2876-e053-2a95a90a949b

Version: 3

Effective Time: 20191230

 

Newton Laboratories, Inc.