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| Product NDC Code | 25047-753 | ||||
|---|---|---|---|---|---|
| Drug Name | Kolorz topical anesthetic cotton candy |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 238910, 856886 |
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| Application Number | part356 | ||||
| Labeler Name | DMG AMERICA, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each gram) Benzocaine 200 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain children under 2 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5, FD&C Blue #1 as a color additive.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.KOLORZ TOPICAL ANESTHETIC TRIPLE MINT Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC CHERRY BURST BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC COTTON CANDY BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 KOLORZ TOPICAL ANESTHETIC PINA COLADA BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SUCRALOSE D&C RED NO. 33 FD&C RED NO. 40 D&C GREEN NO. 5 FD&C YELLOW NO. 5 FD&C BLUE NO. 1
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Triple Mint Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Triple Mint 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Triple Mint
PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cherry Burst Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Cherry Burst 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cherry Burst
PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cotton Candy Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Cotton Candy 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cotton Candy
PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Blue Raspberry Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Blue Raspberry 1 FL OZ (29.6 grams) PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Blue Raspberry
PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Piña Colada Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Piña Colada 1 FL OZ (29.6 grams) RINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Piña Colada
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by DMG America LLC 242 South Dean St., Englewood, NJ 07631
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for teething in children under 2 years of age
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 800-6626383 • www.dmg-america.com
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Avoid contact with eyes. If contact occurs, flush with water.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, consult a doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 59 - 86°F (15 - 30°C). Protect from freezing.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heartrate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsen, see your dentist or doctor promptly. Do not use for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water. If pregnant or breast feeding, consult a doctor before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API