{"active_ingredient":["Menthol 2.5 mg"],"dosage_and_administration":["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."],"effective_time":"20260108","id":"47e26796-0b98-f993-e063-6294a90a3cf1","inactive_ingredient":["annatto, carbomer homopolymer type a, citrus oil, hydroxypropyl cellulose, magnesium chloride, povidone K30, povidone K90, silicon dioxide, xylitol"],"indications_and_usage":["For temporary relief of pain associated with Canker Sores"],"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."],"openfda":{"application_number":["M022"],"brand_name":["Dentemp Canker Cover"],"generic_name":["CANKER COVER"],"is_original_packager":[true],"manufacturer_name":["DOC Brands"],"package_ndc":["73653-213-01","73653-213-02"],"product_ndc":["73653-213"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL","TOPICAL"],"rxcui":["2628246"],"spl_id":["47e26796-0b98-f993-e063-6294a90a3cf1"],"spl_set_id":["2b4b22e9-a03b-fb8f-e063-6394a90a8747"],"substance_name":["MENTHOL"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["Canker Cover 2ct"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding or taking prescription drugs, ask a health care professional before use."],"purpose":["Oral Pain Reliever"],"questions":["833-362-2763 or consumeraffairs@doc-brands.com"],"set_id":"2b4b22e9-a03b-fb8f-e063-6394a90a8747","spl_product_data_elements":["Dentemp Canker Cover Canker Cover MAGNESIUM CHLORIDE XYLITOL SILICON DIOXIDE POVIDONE K90 CARBOMER HOMOPOLYMER TYPE A CITRUS LIMON FRUIT OIL MENTHOL MENTHOL HYDROXYPROPYL CELLULOSE, UNSPECIFIED ANNATTO POVIDONE K30"],"storage_and_handling":["store in a cool, dry place."],"version":"2","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."]}