DENTEMP CANKER SORE SINGLE DOSE- dentemp canker sore tablet, extended release

DenTemp Canker Sore by

Drug Labeling and Warnings

DenTemp Canker Sore by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (per each tablet)

Menthol 2.5 mg

INDICATIONS & USAGE

Indications and Usage

For the temporary relief of pain associated with canker sores

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.

PREGNANCY OR BREASTFEEDING
If pregnant, or breast-feeding or taking prescription drugs, ask a health care professional - before use

INSTRUCTIONS FOR USE

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 AND HANDLING

Other information store in a cool, dry place.

INACTIVE INGREDIENT

Inactive ingredients annato, 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

DOSAGE & ADMINISTRATION

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

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.

PURPOSE

Purpose

Oral Pain Reliever

Dentemp Canker Sore Cover Principal Display Panel

https://lh3.googleusercontent.com/b_IYh2tsbaVrFKjivTRF3TBShQE0y7kGqx4X58-7zz-bvDSokUD0GXphYuB1uiByZerzbw=s85

DenTemp

Canker Cover

Oral Pain Reliever

Clinically Proven

To Relieve Pain & Heat Sores

Helps Heal as Fast as 1 Day

Soothing Relief Up to 12 Hours

Stays on While Eating

6 count

Canker Sore

INGREDIENTS AND APPEARANCE

DENTEMP CANKER SORE  SINGLE DOSE
dentemp canker sore tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-160(NDC:73653-211)
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  in 150 mg

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

Product Characteristics
Color	pink (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: 67659-160-07	6 mg in 1 CARTON; Type 0: Not a Combination Product	04/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/05/2021

Labeler - Team Technologies, Inc (192339703)