Bug Bites - Itch Stopper description, usages, side effects, indications, overdosage, supplying and lots more!

Bug Bites - Itch Stopper

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
Bug Bites - Itch Stopper

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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: ORAL USE ONLY - SHAKE WELL.    Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop 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 - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

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

Bug Bites - Itch Stopper

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

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2274
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANCID BEEF RANCID BEEF 30 [hp_X]
APIS MELLIFERA APIS MELLIFERA 15 [hp_X]
ARANEUS DIADEMATUS ARANEUS DIADEMATUS 15 [hp_X]
ARNICA MONTANA ARNICA MONTANA 15 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_X]
AZADIRACHTA INDICA BARK AZADIRACHTA INDICA BARK 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
Dieffenbachia Seguine Dieffenbachia Seguine 15 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 15 [hp_X]
FORMICA RUFA Formica Rufa 15 [hp_X]
Grindelia Hirsutula Flowering Top GRINDELIA HIRSUTULA FLOWERING TOP 15 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 15 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 15 [hp_X]
LATRODECTUS MACTANS LATRODECTUS MACTANS 15 [hp_X]
LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG 15 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 15 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 15 [hp_X]
PULEX IRRITANS Pulex Irritans 15 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 15 [hp_X]
CITHARACANTHUS SPINICRUS Citharacanthus Spinicrus 15 [hp_X]
LYCOSA TARANTULA LYCOSA TARANTULA 15 [hp_X]
Theridion Curassavicum Theridion Curassavicum 15 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]
VESPA CRABRO Vespa Crabro 15 [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
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2274-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-2274-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-2274-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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