Label: BUG BITES - ITCH STOPPER- pyrogenium, apis mel., aranea diadema, arnica, arsenicum alb., azadirachta indica, bryonia, caladium seguinum, calendula, formica, grindelia, hypericum, lachesis, latrodectus mactans, ledum, mezereum, nux vom., pulex irritans, rhus toxicodendron, tarentula cubensis, tarentula hispana, theridion, thuja occ., vespa crabro, echinacea, hamamelis, solidago pellet

  • NDC Code(s): 55714-2397-1
  • Packager: Newton Laboratories, Inc.
  • 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 November 5, 2018

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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

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  • OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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  • WARNINGS SECTION

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

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  • QUESTIONS SECTION

    newtonlabs.net - Questions? 800 448-7256

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

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  • INACTIVE INGREDIENT SECTION

    Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

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  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

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  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Echinacea 6, Hamamelis 6, Solidago 6x, Apis mel. 15x, Aranea 15x, Arnica 15x, Arsenicum alb. 15x, Azadirachta 15x, Bryonia 15x, Caladium seguinum 15x, Calendula 15, Formica 15x, Grindelia 15x, Hypericum 15x, Lachesis 15x, Latrodectus mac. 15x, Ledum 15x, Mezereum 15x, Nux vom. 15x, Pulex irr. 15x, Rhus tox. 15x, Tarentula cub. 15x, Tarentula hisp. 15x, Theridion 15x, Thuja occ. 15x, Vespa 15x, Pyrogenium 30x.

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  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, take 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.

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  • INDICATIONS & USAGE SECTION

    Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

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  • PACKAGE LABEL
  • INGREDIENTS AND APPEARANCE
    BUG BITES - ITCH STOPPER 
    pyrogenium, apis mel., aranea diadema, arnica, arsenicum alb., azadirachta indica, bryonia, caladium seguinum, calendula, formica, grindelia, hypericum, lachesis, latrodectus mactans, ledum, mezereum, nux vom., pulex irritans, rhus toxicodendron, tarentula cubensis, tarentula hispana, theridion, thuja occ., vespa crabro, echinacea, hamamelis, solidago pellet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2397
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF 30 [hp_X]  in 1 g
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 15 [hp_X]  in 1 g
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS 15 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 15 [hp_X]  in 1 g
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X]  in 1 g
    AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK 15 [hp_X]  in 1 g
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X]  in 1 g
    DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE 15 [hp_X]  in 1 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 15 [hp_X]  in 1 g
    FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA 15 [hp_X]  in 1 g
    LATRODECTUS MACTANS (UNII: XJJ7QA858R) (LATRODECTUS MACTANS - UNII:XJJ7QA858R) LATRODECTUS MACTANS 15 [hp_X]  in 1 g
    GRINDELIA HIRSUTULA FLOWERING TOP (UNII: IDB0NAZ6AI) (GRINDELIA HIRSUTULA FLOWERING TOP - UNII:IDB0NAZ6AI) GRINDELIA HIRSUTULA FLOWERING TOP 15 [hp_X]  in 1 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 15 [hp_X]  in 1 g
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 15 [hp_X]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 15 [hp_X]  in 1 g
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK 15 [hp_X]  in 1 g
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X]  in 1 g
    PULEX IRRITANS (UNII: L63DD62R8R) (PULEX IRRITANS - UNII:L63DD62R8R) PULEX IRRITANS 15 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 15 [hp_X]  in 1 g
    CITHARACANTHUS SPINICRUS (UNII: 3Y5X6RT823) (CITHARACANTHUS SPINICRUS - UNII:3Y5X6RT823) CITHARACANTHUS SPINICRUS 15 [hp_X]  in 1 g
    LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA 15 [hp_X]  in 1 g
    THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L) THERIDION CURASSAVICUM 15 [hp_X]  in 1 g
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]  in 1 g
    VESPA CRABRO (UNII: K3ALM8S49H) (VESPA CRABRO - UNII:K3ALM8S49H) VESPA CRABRO 15 [hp_X]  in 1 g
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X]  in 1 g
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55714-2397-1 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/05/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 11/05/2018
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    Name Address ID/FEI Business Operations
    Newton Laboratories, Inc. 788793610 manufacture(55714-2397)
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