FDA Label for Dentemp Canker Cover
View Indications, Usage & Precautions
Dentemp Canker Cover Product Label
The following document was submitted to the FDA by the labeler of this product Doc Brands. 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.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding or taking prescription drugs, ask a health care professional before use.
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.
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 [email protected]
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