FDA Label for Canker Complete Canker Sore Relief

View Indications, Usage & Precautions

Canker Complete Canker Sore Relief Product Label

The following document was submitted to the FDA by the labeler of this product Wasatch Product Development. 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.

Otc - Active Ingredient



Active ingredient                              Purpose 

Menthol 0.5%                                  Oral Pain Reliever               


Otc - Purpose



Uses        For the temporary relief of pain associated with canker and mouth sores


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of reach of children


Indications & Usage



Stop use and ask a dentist or physician if

- Sore mouth symptoms do not improve in 7 days

- Irritation, pain or redness worsens

- Swelling, rash or fever develops


Warnings



Do not use this product for more than 7 days unless directed by a health professional


Dosage & Administration



Directions

Adults and children 2 years and older              Gently dab medication on the site of irritation with a cotton swab or fingertip

                                                                   Apply to the affected area up to 4 times a day, or as directed by a dentist or physician


Children under 12 years                               Adult supervision should be given in the use of this product

Children under 2 years                                 Consult dentist or physician


Inactive Ingredient



Inactive ingredients:

Calcium/Sodium PVM/MA Copolymer, TX-Factor 5 tm (propietary polypeptide lipid blend), Cellulose Gum, Mineral Oil,  Petrolatum, Lecithin, Chlorella Vulgaris  Extract, Hydrolyzed Lupine Protein, Silica, C12-15 Alkyl  Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Tetrasodium EDTA, Flavor, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Caprylyl Glycol, Stearyl Glycyrrhetinate, Sucralose, DC Red Lake 27


Package Label.Principal Display Panel



Canker Complete   Net wt. .21oz (6g)


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