Label: BEE - BUG BITE- pulex irritans, tarentula cubensis, apis mel., aranea diadema, arnica, formica, grindelia, hypericum, lachesis, latrodectus mactans, ledum, lycopodium, mezereum, rhus toxicodendron, tarentula hispana, theridion, vespa crabro, calendula, echinacea, hamamelis, solidago cream

  • 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 August 1, 2013

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  • INDICATIONS & USAGE SECTION

    Bee - Bug Bite Cream: Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: EXTERNAL USE ONLY:  Ages 2 and up, apply a thin coating up to four times daily to affected area. Repeat as needed or as directed by your healthcare professional. Under age 2, consult a licensed healthcare professional. Avoid eye contact; if eye contact occurs, rinse with water for at least 15 minutes. If allergic response or irritation occurs or persists, discontinue use and consult a licensed healthcare professional.

  • OTC - ACTIVE INGREDIENT SECTION

    Pulex irritans 15x, Tarentula cubensis 15x, Apis mel. 10x, Aranea diadema 10x, Arnica 10x, Formica 10x, Grindelia 10x, Hypericum 10x, Lachesis 10x, Latrodectus mactans 10x, Ledum 10x, Lycopodium 10x, Mezereum 10x, Rhus toxicodendron 10x, Tarentula hispana 10x, Theridion 10x, Vespa crabro 10x, Arnica 3x, Calendula 3x, Echinacea 3x, Hamamelis 3x, Solidago 3x.

  • OTC - PURPOSE SECTION

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

  • INACTIVE INGREDIENT SECTION

    USP Purified Water, Pomace Olive Oil, El Deodorized Cocoa Butter, Beeswax (organic), Jojoba Esters, Soy Lecithin (organic), USP Glycerin, natural (organic, vegetable), USP Gluten-free, non-GMO Cane Alcohol (organic), Grapefruit Seed Extract, Plant preservatives (natural), Gluten-free, non-GMO Xanthan Gum.

  • 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
    BEE - BUG BITE  
    pulex irritans, tarentula cubensis, apis mel., aranea diadema, arnica, formica, grindelia, hypericum, lachesis, latrodectus mactans, ledum, lycopodium, mezereum, rhus toxicodendron, tarentula hispana, theridion, vespa crabro, calendula, echinacea, hamamelis, solidago cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans15 [hp_X]  in 1 g
    Citharacanthus Spinicrus (UNII: 3Y5X6RT823) (Citharacanthus Spinicrus - UNII:3Y5X6RT823) Citharacanthus Spinicrus15 [hp_X]  in 1 g
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera10 [hp_X]  in 1 g
    Araneus Diadematus (UNII: 6T6CO7R3Z5) (Araneus Diadematus - UNII:6T6CO7R3Z5) Araneus Diadematus10 [hp_X]  in 1 g
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana10 [hp_X]  in 1 g
    Formica Rufa (UNII: 55H0W83JO5) (Formica Rufa - UNII:55H0W83JO5) Formica Rufa10 [hp_X]  in 1 g
    Grindelia Hirsutula Flowering Top (UNII: IDB0NAZ6AI) (Grindelia Hirsutula Flowering Top - UNII:IDB0NAZ6AI) Grindelia Hirsutula Flowering Top10 [hp_X]  in 1 g
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum10 [hp_X]  in 1 g
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 g
    Latrodectus Mactans (UNII: XJJ7QA858R) (Latrodectus Mactans - UNII:XJJ7QA858R) Latrodectus Mactans10 [hp_X]  in 1 g
    Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig10 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 g
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark10 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 g
    Lycosa Tarantula (UNII: 86M454L2TT) (Lycosa Tarantula - UNII:86M454L2TT) Lycosa Tarantula10 [hp_X]  in 1 g
    Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum10 [hp_X]  in 1 g
    Vespa Crabro (UNII: K3ALM8S49H) (Vespa Crabro - UNII:K3ALM8S49H) Vespa Crabro10 [hp_X]  in 1 g
    Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top3 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [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 Bark3 [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
    Water (UNII: 059QF0KO0R)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    Royal Jelly (UNII: L497I37F0C)  
    Jojoba Oil (UNII: 724GKU717M)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Glycerin (UNII: PDC6A3C0OX)  
    Alcohol (UNII: 3K9958V90M)  
    Citrus Paradisi Seed (UNII: 12F08874Y7)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Lonicera Japonica Flower (UNII: 4465L2WS4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2003-450 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2013
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2003)
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