KOLORZ TOPICAL ANESTHETIC TRIPLE MINT- benzocaine gel KOLORZ TOPICAL ANESTHETIC CHERRY BURST- benzocaine gel KOLORZ TOPICAL ANESTHETIC COTTON CANDY- benzocaine gel KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY- benzocaine gel KOLORZ TOPICAL ANESTHETIC PINA COLADA- benzocaine gel

KOLORZ TOPICAL ANESTHETIC by

Drug Labeling and Warnings

KOLORZ TOPICAL ANESTHETIC by is a Otc medication manufactured, distributed, or labeled by DMG AMERICA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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.

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

SPL UNCLASSIFIED SECTION

Distributed by DMG America LLC
242 South Dean St., Englewood, NJ 07631

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 - 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 - Piña Colada

Best Taste...
Guaranteed!

kolorz®

Topical Anesthetic Gel
(Benzocaine 20%)
Piña Colada

1 FL OZ (29.6 grams)

INGREDIENTS AND APPEARANCE

KOLORZ TOPICAL ANESTHETIC   TRIPLE MINT
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25047-751
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25047-751-01	29.6 g in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/06/2019

KOLORZ TOPICAL ANESTHETIC   CHERRY BURST
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25047-752
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25047-752-01	29.6 g in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/06/2019

KOLORZ TOPICAL ANESTHETIC   COTTON CANDY
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25047-753
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25047-753-01	29.6 g in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/06/2019

KOLORZ TOPICAL ANESTHETIC   BLUE RASBERRY
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25047-754
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25047-754-01	29.6 g in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/06/2019

KOLORZ TOPICAL ANESTHETIC   PINA COLADA
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25047-755
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25047-755-01	29.6 g in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/06/2019

Labeler - DMG AMERICA, LLC (106792427)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc.		002290302	MANUFACTURE(25047-751, 25047-752, 25047-753, 25047-754, 25047-755) , PACK(25047-751, 25047-752, 25047-753, 25047-754, 25047-755) , LABEL(25047-751, 25047-752, 25047-753, 25047-754, 25047-755)