CANKER COMPLETE CANKER SORE RELIEF - menthol cream 
Wasatch Product Development

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Canker Complete

Active ingredient                              Purpose 

Menthol 0.5%                                  Oral Pain Reliever               

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

Keep this and all drugs out of reach of children

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

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

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 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

Canker Complete   Net wt. .21oz (6g)

CANKER COMPLETE  CANKER SORE RELIEF menthol   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 44717-890 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (Menthol) Menthol 0.5 g  in 100 g

Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM   MINERAL OIL   PETROLATUM   EDETATE SODIUM   CAPRYLYL GLYCOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 44717-890-02 1 TUBE In 1 BOX contains a TUBE (44717-890-01) 1 44717-890-01 6 g In 1 TUBE This package is contained within the BOX (44717-890-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/11/2010

Labeler - Wasatch Product Development (962452533)

Establishment
Name	Address	ID/FEI	Operations
Wasatch Product Development		962452533	manufacture

Revised: 10/2010Wasatch Product Development