Bee - bug Bite Cream

Bee - bug Bite Cream
SPL v1
SPL
SPL Set ID 3d976125-850f-4d85-2b89-6e587d32f5fe
Route
TOPICAL
Published
Effective Date 2013-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pulex Irritans (15 [hp_X]) Citharacanthus Spinicrus (10 [hp_X]) Apis Mellifera (3 [hp_X]) Araneus Diadematus Arnica Montana Formica Rufa Grindelia Hirsutula Flowering Top Hypericum Perforatum Lachesis Muta Venom Latrodectus Mactans Ledum Palustre Twig Lycopodium Clavatum Spore Daphne Mezereum Bark Toxicodendron Pubescens Leaf Lycosa Tarantula Theridion Curassavicum Vespa Crabro Calendula Officinalis Flowering Top Echinacea, Unspecified Hamamelis Virginiana Root Bark/stem Bark Solidago Virgaurea Flowering Top
Inactive Ingredients
Water Olive Oil Cocoa Butter Royal Jelly Jojoba Oil Lecithin, Soybean Glycerin Alcohol Citrus Paradisi Seed Xanthan Gum Lonicera Japonica Flower

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-08-01

Description

Bee - Bug Bite Cream: 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

Bee - Bug Bite Cream: 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

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.

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 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)

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.

Indications & Usage Section (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 (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 (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 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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