FDA Label for Oral Care - Gingivitis

View Indications, Usage & Precautions

Oral Care - Gingivitis 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



Oral Care - Gingivitis   Formulated for symptoms associated with periodontal conditions such as mouth ulcerations, gingivitis, halitosis, teeth pain and gum sensitivity. 


Dosage & Administration Section



Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.


Active Ingredient Section



Aconitum nap. 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Belladonna 20x, Bryonia 20x, Calendula 20x, Chamomilla 20x, Chelidonium majus 20x, Crotalus horridus 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Kreosotum 20x, Merc. viv. 20x, Myrrha 20x, Nux vom. 20x, Phosphorus 20x, Phytolacca 20x, Plantago 20x, Rhus toxicodendron 20x, Silicea 20x, Staphysag. 20x, Chamomilla 8x, Echinacea 8x, Chamomilla 3x, Echinacea 3x.


Purpose Section



Formulated for symptoms associated with periodontal conditions such as mouth ulcerations, gingivitis, halitosis, teeth pain and gum sensitivity.


Inactive Ingredient Section



Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.


Questions? Section



www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256  


Warnings Section



Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.    


Pregnancy Or Breast Feeding Section



Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days


Keep Out Of Reach Of Children Section



Keep out of reach of children


Package Label.




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