Bug Bites - itch Stopper

Bug Bites - itch Stopper
SPL v1
SPL
SPL Set ID b6dc19e4-f1cf-a9cc-458f-952f656ef204
Route
ORAL
Published
Effective Date 2012-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Rancid Beef (30 [hp_X]) Apis Mellifera (15 [hp_X]) Araneus Diadematus (3 [hp_X]) Arnica Montana Arsenic Cation (3+) Azadirachta Indica Bark Bryonia Alba Root Dieffenbachia Seguine Calendula Officinalis Flowering Top Formica Rufa Grindelia Hirsutula Flowering Top Hypericum Perforatum Lachesis Muta Venom Latrodectus Mactans Ledum Palustre Twig Daphne Mezereum Bark Strychnos Nux-vomica Seed Pulex Irritans Toxicodendron Pubescens Leaf Citharacanthus Spinicrus Lycosa Tarantula Theridion Curassavicum Thuja Occidentalis Leafy Twig Vespa Crabro Echinacea, Unspecified Hamamelis Virginiana Root Bark/stem Bark Solidago Virgaurea Flowering Top
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Bug Bites - Itch Stopper   Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

Purpose

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


Medication Information

Purpose

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

Description

Bug Bites - Itch Stopper   Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

Package Label

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.  

Questions Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

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

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section

Bug Bites - Itch Stopper   Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Pyrogenium 30x, Apis mel. 15x, Aranea diadema 15x, Arnica 15x, Arsenicum alb. 15x, Azadirachta indica 15x, Bryonia 15x, Caladium seguinum 15x, Calendula 15, Formica 15x, Grindelia 15x, Hypericum 15x, Lachesis 15x, Latrodectus mactans 15x, Ledum 15x, Mezereum 15x, Nux vom. 15x, Pulex irritans 15x, Rhus toxicodendron 15x, Tarentula cubensis 15x, Tarentula hispana 15x, Theridion 15x, Thuja occ. 15x, Vespa crabro 15x, Echinacea 3x, Hamamelis 3x, Solidago 3x.

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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.  

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Bug Bites - Itch Stopper   Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Pyrogenium 30x, Apis mel. 15x, Aranea diadema 15x, Arnica 15x, Arsenicum alb. 15x, Azadirachta indica 15x, Bryonia 15x, Caladium seguinum 15x, Calendula 15, Formica 15x, Grindelia 15x, Hypericum 15x, Lachesis 15x, Latrodectus mactans 15x, Ledum 15x, Mezereum 15x, Nux vom. 15x, Pulex irritans 15x, Rhus toxicodendron 15x, Tarentula cubensis 15x, Tarentula hispana 15x, Theridion 15x, Thuja occ. 15x, Vespa crabro 15x, Echinacea 3x, Hamamelis 3x, Solidago 3x.

Otc Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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