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Canker Complete Canker Sore Relief

Dosage form: cream
Ingredients: Menthol 0.5g in 100g
Labeler: Wasatch Product Development
NDC Code: 44717-890

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-890
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
MINERAL OIL 
PETROLATUM 
CHLORELLA VULGARIS 
SILICON DIOXIDE 
ALKYL (C12-15) BENZOATE 
TRIBEHENIN 
CERAMIDE 2 
PEG-10 RAPESEED STEROL 
EDETATE SODIUM 
TEA TREE OIL 
CAPRYLYL GLYCOL 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:44717-890-021 TUBE in 1 BOX
1NDC:44717-890-016 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/12/2010
Labeler - Wasatch Product Development (962452533)
Registrant - Wasatch Product Development (962452533)
Establishment
NameAddressID/FEIOperations
Wasatch Product Development962452533manufacture(44717-890)

Revised: 05/2017
 
Wasatch Product Development

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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