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Distributed by DMG America LLC
242 South Dean St., Englewood, NJ 07631
Kolorz Topical Anesthetic Gel
FDA Label NDC 25047-752
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dmg America, Llc for the product Kolorz Topical Anesthetic (NDC 25047-752). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (in each gram), purpose, use, methemoglobinemia warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Gram)
Benzocaine 200 mg
Purpose
Oral Anesthetic
Use
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, consult a doctor before use.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.
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
Other Information
- Store at 59 - 86°F (15 - 30°C).
- Protect from freezing.
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.
Questions Or Comments?
800-6626383 • www.dmg-america.com
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)
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)
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)
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)
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)
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