canker complete

canker complete
SPL v3
SPL
SPL Set ID 4690ea96-a57b-49a4-8742-9471405158d4
Route
topical
Published
Effective Date 2010-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.5 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2010-10-12

Description

Active ingredient                              Purpose  Menthol 0.5%                                  Oral Pain Reliever               


Medication Information

Warnings and Precautions

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

Active Ingredient

Active ingredient                              Purpose 

Menthol 0.5%                                  Oral Pain Reliever               

Indications and 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

Dosage and 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

Description

Active ingredient                              Purpose  Menthol 0.5%                                  Oral Pain Reliever               

Section 50565-1

Keep this and all drugs out of reach of children

Section 51727-6

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

Section 51945-4

Canker Complete   Net wt. .21oz (6g)

Section 55105-1

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


Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

Active ingredient                              Purpose 

Menthol 0.5%                                  Oral Pain Reliever               

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Canker Complete   Net wt. .21oz (6g)

Section 55105-1 (55105-1)

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


Advanced Ingredient Data


Raw Label Data

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