FDA Label for Dentemp Canker Sore Single Dose
View Indications, Usage & Precautions
Dentemp Canker Sore Single Dose Product Label
The following document was submitted to the FDA by the labeler of this product Team Technologies, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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
Otc - Questions
Questions or comments? 833-363-2763 or [email protected]
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
Otc - 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.
Otc - Purpose
Purpose
Oral Pain Reliever
Dentemp Canker Sore Cover Principal Display Panel
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
* Please review the disclaimer below.