Bug 2583l

Bug 2583l
SPL v1
SPL
SPL Set ID 14453db1-05f6-db38-e063-6294a90ae301
Route
ORAL
Published
Effective Date 2024-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lycosa Tarantula (15 [hp_X]) Theridion Curassavicum (6 [hp_X]) Thuja Occidentalis Leafy Twig (30 [hp_X]) Vespa Crabro (16 [hp_X]) Echinacea, Unspecified Hamamelis Virginiana Root Bark/stem Bark Solidago Virgaurea Flowering Top Rancid Beef Apis Mellifera Araneus Diadematus 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
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-03-22

Description

Keep out of reach of children.

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

Keep out of reach of children.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net - Questions? 800 448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

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

Inactive Ingredient Section

USP Purified water; USP Gluten-free non-GMO, organic cane alcohol 20%.

Indications & Usage Section

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

Dosage & Administration Section

Ages 12 and up take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increast to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Hamamelis 6x, Solidago 6x, Apis mel. 15x, Aranea 15x, Arnica 15x, Arsenicum alb. 15x, Bryonia 15x, Caladium seguinum 15x, Calendula 15, Formica 15x, Grindelia 15x, Hypericum 15x, Lachesis 15x, Latrodectus mac. 15x, Ledum 15x, Mezereum 15x, Nux vom. 15x, Pulex irr. 15x, Rhus tox. 15x, Tarentula hisp. 15x, Theridion 15x, Thuja occ. 15x, Vespa 15x, Azadirachta 16x, Pyrogenium 30x.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

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)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800 448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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; USP Gluten-free non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Ages 12 and up take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increast to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Hamamelis 6x, Solidago 6x, Apis mel. 15x, Aranea 15x, Arnica 15x, Arsenicum alb. 15x, Bryonia 15x, Caladium seguinum 15x, Calendula 15, Formica 15x, Grindelia 15x, Hypericum 15x, Lachesis 15x, Latrodectus mac. 15x, Ledum 15x, Mezereum 15x, Nux vom. 15x, Pulex irr. 15x, Rhus tox. 15x, Tarentula hisp. 15x, Theridion 15x, Thuja occ. 15x, Vespa 15x, Azadirachta 16x, Pyrogenium 30x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

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

All Sections (JSON)