Label: INFLAMMATION- anthracinum, pyrogenium, aconitum nap., aloe, apis mel., arnica, arsenicum alb., baptisia, belladonna, bryonia, cantharis, chelidonium majus, crotalus horridus, ferrum phosphoricum, gaultheria procumbens, hepar sulph. calc., iodium, lachesis, nux vom., phosphorus, pulsatilla, rhus toxicodendron, veratrum viride, verbascum, echinacea liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated April 15, 2014

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE SECTION

    Inflammation  Formulated for associated symptoms such as pain, swelling, allergic reactions, congestion and joint problems.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Anthracinum 30x, Pyrogenium 30x, Aconitum nap. 15x, Aloe 15x, Apis mel. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chelidonium maj. 15x, Crotalus hor. 15x, Ferrum phos. 15x, Gaultheria 15x, Hepar sulph. calc. 15x, Iodium 15x, Lachesis 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Veratrum vir. 15x, Verbascum 15x, Apis mel. 3x, Echinacea 3x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as pain, swelling, allergic reactions, congestion and joint problems.

  • 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, 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

  • INGREDIENTS AND APPEARANCE
    INFLAMMATION  
    anthracinum, pyrogenium, aconitum nap., aloe, apis mel., arnica, arsenicum alb., baptisia, belladonna, bryonia, cantharis, chelidonium majus, crotalus horridus, ferrum phosphoricum, gaultheria procumbens, hepar sulph. calc., iodium, lachesis, nux vom., phosphorus, pulsatilla, rhus toxicodendron, veratrum viride, verbascum, echinacea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-8012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacillus Anthracis Immunoserum Rabbit (UNII: 41LZ22DD4N) (Bacillus Anthracis Immunoserum Rabbit - UNII:41LZ22DD4N) Bacillus Anthracis Immunoserum Rabbit30 [hp_X]  in 1 mL
    Rancid Beef (UNII: 29SUH5R3HU) (Rancid Beef - UNII:29SUH5R3HU) Rancid Beef30 [hp_X]  in 1 mL
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus15 [hp_X]  in 1 mL
    Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe15 [hp_X]  in 1 mL
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 mL
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Cation (3+)15 [hp_X]  in 1 mL
    Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root15 [hp_X]  in 1 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [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
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
    Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom15 [hp_X]  in 1 mL
    Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate15 [hp_X]  in 1 mL
    Gaultheria Procumbens Top (UNII: 830295X963) (Gaultheria Procumbens Top - UNII:830295X963) Gaultheria Procumbens Top15 [hp_X]  in 1 mL
    Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide15 [hp_X]  in 1 mL
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine15 [hp_X]  in 1 mL
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [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
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
    Veratrum Viride Root (UNII: 197B3Q7T5Q) (Veratrum Viride Root - UNII:197B3Q7T5Q) Veratrum Viride Root15 [hp_X]  in 1 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-8012-129.57 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/15/2014
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-8012)