DUST - MOLD - DANDER - felis catus skin, canis lupus familiaris skin, ortcyolagus cuniculus skin, equus caballus skin, serinus canaria feather, gallus gallus feather, anas platyrhynchos feather, anser anser feather, melopsittacus undulatus feather, phasianus colchicus feather, meleagris gallopavo feather, felis catus hair, human dander, canis lupus familiaris hair, equus caballus hair, oryctolagus cuniculus hair, human hair, human skin, sheep wool, bos taurus hair, capra hircus hair, cavia porcellus hair 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.

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Dust - Mold - Dander

INDICATIONS & USAGE SECTION

 Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations.

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Allersodes 60x, Allersodes 15x, Candida alb. 15x, Histaminum hydrochloricum 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Antimon. crud. 10x, Apis mel. 10x, Arsenicum alb. 10x, Baptisia 10x, Blatta or. 10x, Bromium 10x, Bryonia 10x, Carduus ben. 10x, Chelidonium maj. 10x, Cinchona 10x, Ipecac. 10x, Lycopodium 10x, Nux vom. 10x, Podoph. pelt. 10x, Rhus tox. 10x, Silicea 10x, Iris versicolor 3x, Solidago 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations.

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:  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.

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

package label

DUST - MOLD - DANDER  
felis catus skin, canis lupus familiaris skin, ortcyolagus cuniculus skin, equus caballus skin, serinus canaria feather, gallus gallus feather, anas platyrhynchos feather, anser anser feather, melopsittacus undulatus feather, phasianus colchicus feather, meleagris gallopavo feather, felis catus hair, human dander, canis lupus familiaris hair, equus caballus hair, oryctolagus cuniculus hair, human hair, human skin, sheep wool, bos taurus hair, capra hircus hair, cavia porcellus hair pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Felis Catus Skin (UNII: 5308ED00EL) (Felis Catus Skin - UNII:5308ED00EL) Felis Catus Skin60 [hp_X]  in 1 g
Canis Lupus Familiaris Skin (UNII: X2W7CLE97T) (Canis Lupus Familiaris Skin - UNII:X2W7CLE97T) Canis Lupus Familiaris Skin60 [hp_X]  in 1 g
Oryctolagus Cuniculus Skin (UNII: Z91WAU43WC) (Oryctolagus Cuniculus Skin - UNII:Z91WAU43WC) Oryctolagus Cuniculus Skin60 [hp_X]  in 1 g
Equus Caballus Skin (UNII: 88VZV9HGT4) (Equus Caballus Skin - UNII:88VZV9HGT4) Equus Caballus Skin60 [hp_X]  in 1 g
Serinus Canaria Feather (UNII: 9EL3384IQY) (Serinus Canaria Feather - UNII:9EL3384IQY) Serinus Canaria Feather60 [hp_X]  in 1 g
Gallus Gallus Feather (UNII: 1FCM16V0FV) (Gallus Gallus Feather - UNII:1FCM16V0FV) Gallus Gallus Feather60 [hp_X]  in 1 g
Anas Platyrhynchos Feather (UNII: 83B65P4796) (Anas Platyrhynchos Feather - UNII:83B65P4796) Anas Platyrhynchos Feather60 [hp_X]  in 1 g
Anser Anser Feather (UNII: 15XI414745) (Anser Anser Feather - UNII:15XI414745) Anser Anser Feather60 [hp_X]  in 1 g
Melopsittacus Undulatus Feather (UNII: 1XY644QKWG) (Melopsittacus Undulatus Feather - UNII:1XY644QKWG) Melopsittacus Undulatus Feather60 [hp_X]  in 1 g
Phasianus Colchicus Feather (UNII: 95ZNE214EZ) (Phasianus Colchicus Feather - UNII:95ZNE214EZ) Phasianus Colchicus Feather60 [hp_X]  in 1 g
Meleagris Gallopavo Feather (UNII: CAC78E2Q9S) (Meleagris Gallopavo Feather - UNII:CAC78E2Q9S) Meleagris Gallopavo Feather60 [hp_X]  in 1 g
Felis Catus Hair (UNII: 1564HD0N96) (Felis Catus Hair - UNII:1564HD0N96) Felis Catus Hair60 [hp_X]  in 1 g
Human Dander (UNII: 30X630U81C) (Human Dander - UNII:30X630U81C) Human Dander60 [hp_X]  in 1 g
Canis Lupus Familiaris Hair (UNII: 05S7L91ZTR) (Canis Lupus Familiaris Hair - UNII:05S7L91ZTR) Canis Lupus Familiaris Hair60 [hp_X]  in 1 g
Equus Caballus Hair (UNII: 4F35XG0149) (Equus Caballus Hair - UNII:4F35XG0149) Equus Caballus Hair60 [hp_X]  in 1 g
Oryctolagus Cuniculus Hair (UNII: 09N62XQ70Y) (Oryctolagus Cuniculus Hair - UNII:09N62XQ70Y) Oryctolagus Cuniculus Hair60 [hp_X]  in 1 g
Human Hair (UNII: 1AWP0DKL4I) (Human Hair - UNII:1AWP0DKL4I) Human Hair60 [hp_X]  in 1 g
Human Skin (UNII: 0EE2343509) (Human Skin - UNII:0EE2343509) Human Skin60 [hp_X]  in 1 g
Sheep Wool (UNII: 503LYG631H) (Sheep Wool - UNII:503LYG631H) Sheep Wool60 [hp_X]  in 1 g
Bos Taurus Hair (UNII: TOQ97Z8644) (Bos Taurus Hair - UNII:TOQ97Z8644) Bos Taurus Hair60 [hp_X]  in 1 g
Capra Hircus Hair (UNII: 16M9MK8C4W) (Capra Hircus Hair - UNII:16M9MK8C4W) Capra Hircus Hair60 [hp_X]  in 1 g
Cavia Porcellus Hair (UNII: KBA5Y6X57N) (Cavia Porcellus Hair - UNII:KBA5Y6X57N) Cavia Porcellus Hair60 [hp_X]  in 1 g
Mesocricetus Auratus Hair (UNII: EFG2YD102P) (Mesocricetus Auratus Hair - UNII:EFG2YD102P) Mesocricetus Auratus Hair60 [hp_X]  in 1 g
Wheat Gluten (UNII: 1534K8653J) (Wheat Gluten - UNII:1534K8653J) Wheat Gluten15 [hp_X]  in 1 g
Aspergillus Niger Var. Niger (UNII: 9IOA40ANG6) (Aspergillus Niger Var. Niger - UNII:9IOA40ANG6) Aspergillus Niger Var. Niger15 [hp_X]  in 1 g
Cladosporium Herbarum (UNII: O64JF11198) (Cladosporium Herbarum - UNII:O64JF11198) Cladosporium Herbarum15 [hp_X]  in 1 g
House Dust (UNII: EYO007VX98) (House Dust - UNII:EYO007VX98) House Dust15 [hp_X]  in 1 g
Candida Albicans (UNII: 4D7G21HDBC) (Candida Albicans - UNII:4D7G21HDBC) Candida Albicans15 [hp_X]  in 1 g
Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride15 [hp_X]  in 1 g
Saccharomyces Cerevisiae (UNII: 978D8U419H) (Saccharomyces Cerevisiae - UNII:978D8U419H) Saccharomyces Cerevisiae15 [hp_X]  in 1 g
Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG) Ustilago Maydis15 [hp_X]  in 1 g
Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide10 [hp_X]  in 1 g
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera10 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Cation (3+)10 [hp_X]  in 1 g
Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root10 [hp_X]  in 1 g
Blatta Orientalis (UNII: 535787266D) (Blatta Orientalis - UNII:535787266D) Blatta Orientalis10 [hp_X]  in 1 g
Bromine (UNII: SBV4XY874G) (Bromine - UNII:SBV4XY874G) Bromine10 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
Centaurea Benedicta (UNII: 6L5ZL09795) (Centaurea Benedicta - UNII:6L5ZL09795) Centaurea Benedicta10 [hp_X]  in 1 g
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus10 [hp_X]  in 1 g
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 g
Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac10 [hp_X]  in 1 g
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum10 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 g
Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide10 [hp_X]  in 1 g
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 g
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2311-128 g in 1 BOTTLE, GLASS
2NDC:55714-2311-257 g in 1 BOTTLE, GLASS
3NDC:55714-2311-07 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2311)

Revised: 3/2011
Document Id: 4877a63a-1508-6adb-8d42-f30033600d58
Set id: 24d528b5-2de6-93a7-3039-473d3fa13717
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.