CANKER COMPLETE CANKER SORE RELIEF- menthol cream

Canker Complete by

Drug Labeling and Warnings

Canker Complete by is a Otc medication manufactured, distributed, or labeled by Wasatch Product Development. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Canker Complete   Net wt. .21oz (6g)

INGREDIENTS AND APPEARANCE

CANKER COMPLETE  CANKER SORE RELIEF
menthol cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CERAMIDE 2 (UNII: C04977SRJ5)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
EDETATE SODIUM (UNII: MP1J8420LU)
TEA TREE OIL (UNII: VIF565UC2G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44717-890-02	1 in 1 BOX	10/12/2010
1	NDC: 44717-890-01	6 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/12/2010

Labeler - Wasatch Product Development (962452533)

Registrant - Wasatch Product Development (962452533)

Establishment
Name	Address	ID/FEI	Business Operations
Wasatch Product Development		962452533	manufacture(44717-890)