Bee - Bug Bite description, usages, side effects, indications, overdosage, supplying and lots more!

Bee - Bug Bite

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Bee - Bug Bite Cream

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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 Type Human otc drug label Item Code (Source) NDC:55714-2003
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PULEX IRRITANS Pulex Irritans 15 [hp_X]
CITHARACANTHUS SPINICRUS Citharacanthus Spinicrus 15 [hp_X]
APIS MELLIFERA APIS MELLIFERA 10 [hp_X]
ARANEUS DIADEMATUS ARANEUS DIADEMATUS 10 [hp_X]
ARNICA MONTANA ARNICA MONTANA 10 [hp_X]
FORMICA RUFA Formica Rufa 10 [hp_X]
Grindelia Hirsutula Flowering Top GRINDELIA HIRSUTULA FLOWERING TOP 10 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 10 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 10 [hp_X]
LATRODECTUS MACTANS LATRODECTUS MACTANS 10 [hp_X]
LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 10 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 10 [hp_X]
LYCOSA TARANTULA LYCOSA TARANTULA 10 [hp_X]
Theridion Curassavicum Theridion Curassavicum 10 [hp_X]
VESPA CRABRO Vespa Crabro 10 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X]
SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
water
olive oil
COCOA BUTTER
ROYAL JELLY
Jojoba Oil
LECITHIN, SOYBEAN
GLYCERIN
ALCOHOL
CITRUS PARADISI SEED
XANTHAN GUM
LONICERA JAPONICA FLOWER

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2003-4 50 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-08-01


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