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 
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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Bee - Bug Bite Cream

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

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)

Revised: 8/2013
Document Id: d6554828-640f-4b4e-03d1-cf7bc40b378a
Set id: 3d976125-850f-4d85-2b89-6e587d32f5fe
Version: 1
Effective Time: 20130801
 
Newton Laboratories, Inc.