Otc - Active Ingredient
Active ingredient Purpose
Menthol 0.5% Oral Pain Reliever
Canker Complete
FDA Label NDC 44717-890
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wasatch Product Development for the product Canker Complete (NDC 44717-890). 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 - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Image Of Secondary Label (Secondary)
Package Label.Principal Display Panel
Canker Complete Net wt. .21oz (6g)
Image Of Primary Label (Primary)
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