FDA Label for Ear Wax Build-up
View Indications, Usage & Precautions
Ear Wax Build-up Product Label
The following document was submitted to the FDA by the labeler of this product Newton Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage Section
Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.
Dosage & Administration Section
Directions: 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 increase to full dose.
Otc - Active Ingredient Section
Equal parats of Alumina 15x, Carbo veg. 15x, Causticum 15x, Conium 15x, Graphites 15x, Kali bic. 15x, Kali mur. 15x, Lachesis 15x, Lycopodium 15x, Petroleum 15x, Pulsatilla 15x, Sabadilla 15x, Sepia 15x, Silicea 15x, Spongia 15x, Verbascum 15x, Viola odorata 15x, Elaps 30x.
Otc - Purpose Section
Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
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 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
Keep out of reach of children.
Package Label
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