Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Bug Bites - Itch Stopper Liquid
FDA Label NDC 55714-2583
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Bug Bites - Itch Stopper (NDC 55714-2583). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - keep out of reach of children section, otc - pregnancy or breast feeding section, warnings section, questions section, dosage & administration section, inactive ingredient section, otc - purpose section, otc - active ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package Label (N038 L01)
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