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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DenTemp Canker Cover- canker cover tablet, extended relief

Active Ingredient (per each tablet)

Menthol 2.5 mg

Indications and Usage

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.

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

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

Other information store in a cool, dry place.

Inactive ingredients annato, carbomer homopolymer type a, citrus oil, hydroxypropyl - cellulose, magnesium chloride, povidone K30, povidone K90,silicon dioxide, xylitol

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

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. In case of accidental overdose,get medical help or contact a

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

Purpose

Oral Pain Reliever

Dentemp Canker Sore Cover Principal Display Panel

Canker Sore

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

DENTEMP CANKER SORE  SINGLE DOSE
dentemp canker sore tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-160(NDC:73653-211)
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 150 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (Pink (one side pink, one side white)) Scoreno score
ShapeROUNDSize10mm
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67659-160-076 mg in 1 CARTON; Type 0: Not a Combination Product04/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/05/2021
Labeler - Team Technologies, Inc (192339703)

Revised: 5/2021
Document Id: c2dcf032-66e2-6854-e053-2a95a90ab640
Set id: beed8392-2281-b8be-e053-2995a90aef9f
Version: 2
Effective Time: 20210521
 
Team Technologies, Inc