Indications And Usage Section
Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.
Ear Care Pellet
FDA Label NDC 55714-1737
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 Ear Care (NDC 55714-1737). 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 indications and usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) one to four times daily or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.
Otc - Active Ingredient Section
Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Apis mellifica 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Dulcamara 15x, Ferrum phosphoricum 15x, Hepar sulphuris calcareum 15x, Kali sulphuricum 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Mezereum 15x, Phosphorus 15x, Plantago major 15x, Pulsatilla 15x, Silicea 15x, Tellurium metallicum 16x, Verbascum thapsus 15x, Influenzinum 30x.
Otc - Purpose Section
Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.
Inactive Ingredient Section
Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
Questions Section
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
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.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children Section
WARNINGS: Keep out of reach of children.
Package Label
Package Label (F006 P01)
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