Bug Bites - Itch Stopper
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2024-03-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:26:26
Label at a glance#
ProductBug Bites - Itch Stopper
Active ingredientLYCOSA TARANTULA, THERIDION CURASSAVICUM, THUJA OCCIDENTALIS LEAFY TWIG, VESPA CRABRO, ECHINACEA, UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, SOLIDAGO VIRGAUREA FLOWERING TOP, RANCID BEEF, APIS MELLIFERA, ARANEUS DIADEMATUS, ARNICA MONTANA, ARSENIC TRIOXIDE, 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
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
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
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.
INACTIVE INGREDIENT SECTION
USP Purified water; USP Gluten-free non-GMO, organic cane alcohol 20%.
OTC - PURPOSE SECTION
Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.
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.
INDICATIONS & USAGE SECTION
Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2583-1 | Bug Bites - Itch Stopper | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2583 | 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 [NEWTON LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20240324_14453db1-05f6-db38-e063-6294a90ae301.zip |
Products#
Every source-derived product name is available through these pages.
- 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
- LYCOSA TARANTULA
- THERIDION CURASSAVICUM
- THUJA OCCIDENTALIS LEAFY TWIG
- VESPA CRABRO
- ECHINACEA, UNSPECIFIED
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
- SOLIDAGO VIRGAUREA FLOWERING TOP
- WATER
- ALCOHOL
- RANCID BEEF
- APIS MELLIFERA
- ARANEUS DIADEMATUS
- ARNICA MONTANA
- ARSENIC TRIOXIDE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2583 | 55714-2583-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | 14453db1-05f6-db38-e063-6294a90ae301 | 2024-03-22 | Warnings | 55714-2583-1 55714-2583 55714258301 144510b9-90b0-b2ca-e063-6394a90a3d09 14453db1-05f6-db38-e063-6294a90ae301 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.