20131018

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DETOXIFIER - uricum acidum, benzoicum acidum, berber. vulg.

, bryonia, cantharis , carduus


benedictus , ceanothus , chelidonium majus , chionanthus virginica, cinchona, dios corea, dolichos ,
iris vers icolor, juniperus com., nux vom., ptelea, taraxacum, carduus mar., cynara s colymus ,
s olidago pellet
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.
----------
Detoxifier

INDICATIONS & USAGE SECTION


Detoxifier Formulated for liver and kidney functions and for symptoms associated with toxicity such as
newborn jaundice, hypersensitivity and sluggish elimination.

DOSAGE & ADMINISTRATION SECTION


Directions : Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) at bedtime or
as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.
Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION


Uricum acidum 15x, Benzoicum acidum 10x, Berber. vulg. 10x, Bryonia 10x, Cantharis 10x, Carduus
benedictus 10x, Ceanothus 10x, Chelidonium majus 10x, Chionanthus virginica 10x, Cinchona 10x,
Dioscorea 10x, Dolichos 10x, Iris versicolor 10x, Juniperus com. 10x, Nux vom. 10x, Ptelea
10x,Taraxacum 10x, Carduus mar. 3x, Cynara scolymus 3x, Solidago 3x,Taraxacum 3x.

OTC - PURPOSE SECTION


Formulated for liver and kidney functions and for symptoms associated with toxicity such as newborn
jaundice, hypersensitivity and sluggish elimination.

INACTIVE INGREDIENT SECTION


Inactive Ingredients : Gluten-free, non-GMO, beet-derived sucrose pellets.

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, 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

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 pellet

Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:55714-170 0

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety


Ing redient Name Basis o f Streng th Streng th
15 [hp_X]
Uric Ac id (UNII: 26 8 B43MJ25) (Uric Ac id - UNII:26 8 B43MJ25) Uric Ac id
in 1 g
10 [hp_X]
Be nz o ic Ac id (UNII: 8 SKN0 B0 MIM) (Be nz o ic Ac id - UNII:8 SKN0 B0 MIM) Be nz o ic Ac id
in 1 g
Be rbe ris Vulg a ris Ro o t Ba rk (UNII: 1TH8 Q 20 J0 U) (Be rbe ris Vulga ris Ro o t Ba rk - Be rbe ris Vulga ris Ro o t 10 [hp_X]
UNII:1TH8 Q 20 J0 U) Ba rk in 1 g
10 [hp_X]
Bryo nia Alba Ro o t (UNII: T7J0 46 YI2B) (Bryo nia Alba Ro o t - UNII:T7J0 46 YI2B) Bryo nia Alba Ro o t
in 1 g
10 [hp_X]
Lytta Ve sic a to ria (UNII: 3Q 0 34RO 3BT) (Lytta Ve sic a to ria - UNII:3Q 0 34RO 3BT) Lytta Ve sic a to ria
in 1 g
10 [hp_X]
Ce nta ure a Be ne dic ta (UNII: 6 L5ZL0 9 79 5) (Ce nta ure a Be ne dic ta - UNII:6 L5ZL0 9 79 5) Ce nta ure a Be ne dic ta
in 1 g
Ce a no thus Ame ric a nus Le a f (UNII: 25B1Y14T8 N) (Ce a no thus Ame ric a nus Le a f - Ce a no thus Ame ric a nus 10 [hp_X]
UNII:25B1Y14T8 N) Le a f in 1 g
10 [hp_X]
Che lido nium Ma j us (UNII: 7E8 8 9 U5RNN) (Che lido nium Ma jus - UNII:7E8 8 9 U5RNN) Che lido nium Ma jus
in 1 g
Chio na nthus Virg inic us Ba rk (UNII: S9 Y4B22U2E) (Chio na nthus Virginic us Ba rk - Chio na nthus Virginic us 10 [hp_X]
UNII:S9 Y4B22U2E) Ba rk in 1 g
Cinc ho na O ffic ina lis Ba rk (UNII: S0 0 3A158 SB) (Cinc ho na O ffic ina lis Ba rk - 10 [hp_X]
Cinc ho na O ffic ina lis Ba rk
UNII:S0 0 3A158 SB) in 1 g
Dio sc o re a Villo sa Tube r (UNII: IWY3IWX2G8 ) (Dio sc o re a Villo sa Tube r - 10 [hp_X]
Dio sc o re a Villo sa Tube r
UNII:IWY3IWX2G8 ) in 1 g
Muc una Prurie ns Fruit Tric ho me (UNII: 3E271BSI0 C) (Muc una Prurie ns Fruit Tric ho me - Muc una Prurie ns Fruit 10 [hp_X]
UNII:3E271BSI0 C) Tric ho me in 1 g
10 [hp_X]
Iris Ve rsic o lo r Ro o t (UNII: X43D4L3DQ C) (Iris Ve rsic o lo r Ro o t - UNII:X43D4L3DQ C) Iris Ve rsic o lo r Ro o t
in 1 g
10 [hp_X]
Junipe r Be rry (UNII: O 8 4B519 4RL) (Junipe r Be rry - UNII:O 8 4B519 4RL) Junipe r Be rry
in 1 g
Stryc hno s Nux-vo mic a Se e d (UNII: 26 9 XH139 19 ) (Stryc hno s Nux-vo mic a Se e d - Stryc hno s Nux-vo mic a 10 [hp_X]
UNII:26 9 XH139 19 ) Se e d in 1 g
10 [hp_X]
Pte le a Trifo lia ta Ba rk (UNII: 5KQ R6 FTT0 D) (Pte le a Trifo lia ta Ba rk - UNII:5KQ R6 FTT0 D) Pte le a Trifo lia ta Ba rk
in 1 g
10 [hp_X]
Ta ra xa c um O ffic ina le (UNII: 39 9 8 1FM375) (Ta ra xa c um O ffic ina le - UNII:39 9 8 1FM375) Ta ra xa c um O ffic ina le
in 1 g
Silybum Ma ria num Se e d (UNII: U9 46 SH9 5EE) (Silybum Ma ria num Se e d - 3 [hp_X]
Silybum Ma ria num Se e d
UNII:U9 46 SH9 5EE) in 1 g
3 [hp_X]
Cyna ra Sc o lymus Le a f (UNII: B71UA545DE) (Cyna ra Sc o lymus Le a f - UNII:B71UA545DE) Cyna ra Sc o lymus Le a f
in 1 g
So lida g o Virg a ure a Flo we ring To p (UNII: 540 5K23S50 ) (So lida go Virga ure a Flo we ring So lida go Virga ure a 3 [hp_X]
To p - UNII:540 5K23S50 ) Flo we ring To p in 1 g

Inactive Ing redients


Ing redient Name Streng th
Suc ro se (UNII: C151H8 M554)

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:55714-170 0 -1 28 .35 g in 1 BO TTLE, GLASS
2 NDC:55714-170 0 -2 56 .7 g in 1 BO TTLE, GLASS
3 NDC:55714-170 0 -0 7.0 8 g in 1 BO TTLE, GLASS

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
una ppro ve d ho me o pa thic 0 3/0 1/20 11

Labeler - Newton Laboratories , Inc. (788793610)


Registrant - Newton Laboratories , Inc. (788793610)

Establishment
Name Ad d re s s ID/FEI Bus ine s s Op e rations
Ne wto n La bo ra to rie s, Inc . 78 8 79 36 10 MANUFACTURE(55714-170 0 )

Revised: 3/2011 Newton Laboratories, Inc.

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