Kolorz® - DailyMed Details

Kolorz®

SPL v3

SPL

SPL Set ID 0f90b227-f938-4e1a-a79e-1967b1a0477e

Route

DENTAL

Published

Effective Date 2021-10-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-09-06

Description

Drug Facts

Purpose

Oral Anesthetic

Medication Information

Purpose

Oral Anesthetic

Description

Drug Facts

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 53414-9

If pregnant or breast feeding, consult a doctor before use.

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

Do Not Use

for teething
in children under 2 years of age

Allergy Alert

Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.

Other Information

Store at 59 - 86°F (15 - 30°C).
Protect from freezing.

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.

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

When Using This Product

Avoid contact with eyes. If contact occurs, flush with water.

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

Active Ingredients (in Each Gram)

Benzocaine 200 mg

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 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 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 Piña Colada

Best Taste...

Guaranteed!

kolorz^®

Topical Anesthetic Gel

(Benzocaine 20%)

Piña Colada

1 FL OZ (29.6 grams)

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)

Structured Label Content

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 53414-9 (53414-9)

If pregnant or breast feeding, consult a doctor before use.

Purpose

Oral Anesthetic

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

Do Not Use (Do not use)

for teething
in children under 2 years of age

Allergy Alert (Allergy alert)

Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.

Other Information (Other information)

Store at 59 - 86°F (15 - 30°C).
Protect from freezing.

Sore Throat Warning (Sore throat warning)

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 Or Comments? (Questions or comments?)

800-6626383 • www.dmg-america.com

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, flush with water.

Methemoglobinemia Warning (Methemoglobinemia warning)

pale, gray, or blue colored skin (cyanosis)
headache
rapid heartrate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Benzocaine 200 mg

Principal Display Panel 29.6 Grams Bottle Label Triple Mint (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 Cherry Burst (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 Cotton Candy (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 Piña Colada (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)

Principal Display Panel 29.6 Grams Bottle Label Blue Raspberry (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)

Advanced Ingredient Data

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"unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C GREEN NO. 5", "unii": "8J6RDU8L9X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C GREEN NO. 5", "unii": "8J6RDU8L9X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.", "42229-5": "Drug Facts", "50565-1": "KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.", "53414-9": "If pregnant or breast feeding, consult a doctor before use.", "Purpose": "Oral Anesthetic", "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", "Do not use": "for teething in children under 2 years of age", "Allergy alert": "Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.", "Other information": "Store at 59 - 86°F (15 - 30°C). Protect from freezing.", "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.", "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", "When using this product": "Avoid contact with eyes. If contact occurs, flush with water.", "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", "Active ingredients (in each gram)": "Benzocaine 200 mg", "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 - 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 - 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 - Piña Colada": "Best Taste... Guaranteed! kolorz ® Topical Anesthetic Gel (Benzocaine 20%) Piña Colada 1 FL OZ (29.6 grams)", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.852490 · Updated: 2026-03-14T23:05:18.894850