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 
DMG AMERICA, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KOLORZ® TOPICAL ANESTHETIC

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

Other information

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

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 - 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
KOLORZ TOPICAL ANESTHETIC   TRIPLE MINT
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25047-751
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-751-0129.6 g in 1 BOTTLE; Type 0: Not a Combination Product09/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/06/2019
KOLORZ TOPICAL ANESTHETIC   CHERRY BURST
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25047-752
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-752-0129.6 g in 1 BOTTLE; Type 0: Not a Combination Product09/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/06/2019
KOLORZ TOPICAL ANESTHETIC   COTTON CANDY
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25047-753
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-753-0129.6 g in 1 BOTTLE; Type 0: Not a Combination Product09/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/06/2019
KOLORZ TOPICAL ANESTHETIC   BLUE RASBERRY
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25047-754
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-754-0129.6 g in 1 BOTTLE; Type 0: Not a Combination Product09/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/06/2019
KOLORZ TOPICAL ANESTHETIC   PINA COLADA
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25047-755
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-755-0129.6 g in 1 BOTTLE; Type 0: Not a Combination Product09/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/06/2019
Labeler - DMG AMERICA, LLC (106792427)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc.002290302MANUFACTURE(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)

Revised: 10/2021
Document Id: 0d8c3056-ede4-46b9-a1d1-fb68cfe7b7b6
Set id: 0f90b227-f938-4e1a-a79e-1967b1a0477e
Version: 2
Effective Time: 20211001
 
DMG AMERICA, LLC