说明与适用边界
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spl product data elements
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
spl unclassified section
Drug Facts
Distributed by DMG America LLC 242 South Dean St., Englewood, NJ 07631
活性成分 / Active ingredient
Active ingredients (in each gram) Benzocaine 200 mg
用途 / Purpose
Purpose Oral Anesthetic
适应证 / Indications and usage
Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
警告 / Warnings
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.
禁用事项 / Do not use
Do not use for teething in children under 2 years of age
使用中 / When using
When using this product Avoid contact with eyes. If contact occurs, flush with water.
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast feeding, consult a doctor before use.
儿童安全 / 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.
用法用量原文 / Dosage and administration
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
储存 / Storage and handling
Other information Store at 59 - 86°F (15 - 30°C). Protect from freezing.
辅料 / Inactive ingredients
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
Questions or comments? 800-6626383 • www.dmg-america.com
package label principal display panel
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
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20211001
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

