DENTEMP CANKER COVER- canker cover tablet, extended release

Dentemp Canker Cover by

Drug Labeling and Warnings

Dentemp Canker Cover by is a Otc medication manufactured, distributed, or labeled by iiMED Medical Mexicana S. DE R.L. DE C.V., Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (per each tablet)

Menthol 2.5 mg

PURPOSE

Purpose

Oral Pain Reliever

Indications for Use

Indicationsfor the temporary relief of pain associated with Canker Sores

PREGNANCY OR BREASTFEEDING

If pregnant, or breast-feeding or taking prescription drugs, ask a health care professional

before use

WARNINGS

Warnings

Do not use this product for more than 7 days unless directed by a dentist or doctor.

Stop use and ask a dentist or doctor if .sore mouth symptoms do not improve in 7 days

.irritation, pain or redness worsens .swelling, rash or fever develops

Do not exceed recommended dosage.

Warnings

Keep out of reach of children.In case of accidental overdose,get medical help or contact a

Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

Directions .adults and children 5 years of age and older,apply up to 3 tablets per day,

as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side on

the sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between the

cheek and gum or near the teeth or lip) break the tablet along the score and use half. Some

discomfort may occur during the first few minutes, but will quickly subside, followed by hours of

soothing relief. Within 30 minutes the tablet forms a clear, gel-like bandage that seals and

protects the sore for hours before dissolving. Do not remove the tablet before it dissolves. In

case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while

washing with warm water. Do not use any instrument to remove the tablet.

.children under 5 years, ask a doctor

STORAGE

Other informationstore in a cool, dry place.

INACTIVE INGREDIENTS

Inactive ingredientsannato, carbomer homopolymer type a, citrus oil, hydroxypropyl

cellulose, magnesium chloride, povidone K30, povidone K90,silicon dioxide, xylitol

QUESTIONS

Questions or comments?833-363-2763 or consumeraffairs@doc-brands.com

DENTEMP CANKER COVER PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTEMP CANKER COVER 
canker cover tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83062-211(NDC:73653-211)
Route of Administration	TOPICAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 mg  in 150 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
XYLITOL (UNII: VCQ006KQ1E)
ANNATTO (UNII: 6PQP1V1B6O)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)

Product Characteristics
Color	pink (one side pink, one side white)	Score	no score
Shape	ROUND	Size	10mm
Flavor	CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83062-211-07	6 in 1 CARTON	02/20/2020
1	NDC: 83062-211-06	150 mg in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	02/20/2020

Labeler - iiMED Medical Mexicana S. DE R.L. DE C.V. (812894376)

Registrant - Team Technologies, Inc (192339703)