Kolorz Sixty Second Fluoride Gel
Product Images NDC 25047-772

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Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Kolorz Sixty Second Fluoride (NDC 25047-772). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dmg America, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Principal Display Panel (480 ml Bottle Label)

Principal Display Panel (480 ml Bottle Label)
This is a fluoride gel used for topical application to prevent dental caries. The dosage and administration instructions advise using the gel and tray(s) for up to four minutes, after which the excess gel should be expectorated and not consumed, drank, or rinsed out of the mouth for 30 minutes. The gel contains a proprietary acidulated phosphate flavored base with 1.23% fluoride, derived from 2.72% sodium fluoride, and sweetened with sucralose, but not containing aspartame or saccharin. The emergency response number is 1-800-535-5053. The product is made in the USA and distributed by DMG America LLC, which lists the caution that the product is for professional use only, and should be shaken well before use. The container holds 1.5oz.*
FDA Label Image

Principal Display Panel (480 ml Bottle Label)

Principal Display Panel (480 ml Bottle Label)
This text describes a fluoride gel product indicated for topical application to protect against dental caries. It contains 1.23% fluoride, sweetened with Sucralose and does not contain Aspartame or Saccharin. The text provides dosage and administration instructions that involve applying the fluoride gel on each tooth surface for 60 seconds or up to 10 minutes while biting down and using a slight chewing motion for interproximal coverage. The patient should not eat, drink, or rinse for 30 minutes after use. The gel comes in a 16 fl oz bottle and is for professional use only. The text warns users to keep the gel out of reach of children and not to swallow. If ingested in a dosage of less than 100mg, contact poison control. The text also provides emergency response contact information and storage instructions.*
FDA Label Image

Principal Display Panel (480 ml Bottle Label)

Principal Display Panel (480 ml Bottle Label)
This is a description of a topical fluoride gel used to protect against dental caries. The product is administered using fluoride trays filled with gel, which are placed in the mouth for up to 4 minutes while the patient bites down and makes a slight chewing motion for complete coverage. The gel contains 1.23% fluoride ion from 2.72% sodium fluoride in a sweetened, acidulated phosphate flavored gel base. The product is sweetened with sucralose and does not contain aspartame or saccharin. It does not contain gluten, but it is for professional use only and should be kept out of reach of children. The product should not be swallowed, and emergency response should be contacted if more than 100mg is ingested. The gel should be stored between 68-77°F and should be shaken well before each use.*
FDA Label Image

Principal Display Panel (480 ml Bottle Label)

Principal Display Panel (480 ml Bottle Label)
This is a description of a fluoride gel that is indicated for topical application to protect against dental caries. It contains 1.23% fluoride from 2.72% sodium fluoride and is sweetened with sucralose, without aspartame or saccharin, in a blue raspberry-flavored gel base. The dosage and administration are specified, and it is advised not to eat, drink or rinse for 30 minutes after use. The product warning states not to be swallowed and to keep out of reach of children, with poison control to be contacted if dosed with less than 100mg. The fluoride gel should be kept at room temperature, and the product is specified as gluten-free. The item is for professional use only, and the user should shake well before each use. In case of emergency, the infovac number is provided.*
FDA Label Image

Principal Display Panel (480 ml Bottle Label)

Principal Display Panel (480 ml Bottle Label)
This is a description of a dental product, an APF Topical Fluoride Gel with cotton candy flavor, designed for the protection against dental caries. It should be applied topically to the tooth surface using a tray inserted into the patient's mouth. The recommended dosage involves having the patient sit still for 60 seconds while the gel is in place, followed by the removal of the tray and expectoration of the remaining gel. The use of the product is cautioned to be limited to professional application only. The product contains sodium fluoride and proprietary aculated phosphate Havore gl base, along with Sweetened with Sucalose. It does not contain Aspartame or Saccharin and is gluten-free. The product should be kept out of reach of children, and in the case of ingestion, contact poison control. It should be stored between 68-77° and protected from freezing, while it contains DAC Red #33. Emergency response can be contacted through a provided phone number, and the product information includes a reorder number.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.