Label: DENTEMP CANKER SORE SINGLE DOSE- dentemp canker sore tablet, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 67659-160-07 - Packager: Team Technologies, Inc
- This is a repackaged label.
- Source NDC Code(s): 73653-211
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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
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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
- INACTIVE INGREDIENT
- QUESTIONS
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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
- PURPOSE
- Dentemp Canker Sore Cover Principal Display Panel
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INGREDIENTS AND APPEARANCE
DENTEMP CANKER SORE SINGLE DOSE
dentemp canker sore tablet, extended releaseProduct 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)
