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 DOC Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (per each tablet)

Menthol 2.5 mg

Purpose

Ora pain reliever

Indications

for the temporary relief of pain associated with Canker Sores

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding or taking prescription drugs, ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

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

adults and children 5 years of age and older, apply up to 3 tablets a 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.

Other information

store in a cool, dry place.

Inactive ingredients

annatto, carbomer homopolymer type a, citrus oil, hydroxypropyl cellulose, magnesium chloride, povidone K30, povidone K90, silicon dioxide, xylitol

Questions or comments?

833-362-2763 or consumeraffairs@doc-brands.com

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: 73653-212
Route of Administration	ORAL, TOPICAL

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

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

Product Characteristics
Color	pink (ONE SIDE PINK, ONE SIDE WHITE)	Score	no score
Shape	ROUND	Size	10mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73653-212-04	4 in 1 CARTON	02/02/2023
1	NDC: 73653-212-01	1 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	02/02/2023

Labeler - DOC Brands (081254601)