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 liquid

  • NDC Code(s): 55714-2396-0, 55714-2396-1
  • 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 24, 2020

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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • 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.

  • DOSAGE & ADMINISTRATION SECTION

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

  • QUESTIONS SECTION

    newtonlabs.net - Questions? 800 448-7256

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

  • INACTIVE INGREDIENT SECTION

    USP Purified water; USP Gluten-free non-GMO, organic cane alcohol 20%.

  • OTC - PURPOSE SECTION


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

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Echinacea 6x, Hamamelis 6x, 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.

  • INDICATIONS & USAGE SECTION

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

  • PACKAGE LABEL

    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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2396
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITHARACANTHUS SPINICRUS (UNII: 3Y5X6RT823) (CITHARACANTHUS SPINICRUS - UNII:3Y5X6RT823) CITHARACANTHUS SPINICRUS15 [hp_X]  in 1 mL
    LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA15 [hp_X]  in 1 mL
    THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L) THERIDION CURASSAVICUM15 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]  in 1 mL
    VESPA CRABRO (UNII: K3ALM8S49H) (VESPA CRABRO - UNII:K3ALM8S49H) VESPA CRABRO15 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]  in 1 mL
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA15 [hp_X]  in 1 mL
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS15 [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 TRIOXIDE15 [hp_X]  in 1 mL
    AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK15 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
    DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE15 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]  in 1 mL
    FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA15 [hp_X]  in 1 mL
    GRINDELIA HIRSUTULA FLOWERING TOP (UNII: IDB0NAZ6AI) (GRINDELIA HIRSUTULA FLOWERING TOP - UNII:IDB0NAZ6AI) GRINDELIA HIRSUTULA FLOWERING TOP15 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM15 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
    LATRODECTUS MACTANS (UNII: XJJ7QA858R) (LATRODECTUS MACTANS - UNII:XJJ7QA858R) LATRODECTUS MACTANS15 [hp_X]  in 1 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG15 [hp_X]  in 1 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK15 [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
    PULEX IRRITANS (UNII: L63DD62R8R) (PULEX IRRITANS - UNII:L63DD62R8R) PULEX IRRITANS15 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2396-015 mL in 1 BOTTLE, GLASS; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)11/05/201808/01/2019
    2NDC:55714-2396-130 mL in 1 BOTTLE, GLASS; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug11/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/05/2018
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2396)
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