Label: 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

  • NDC Code(s): 25047-751-01, 25047-752-01, 25047-753-01, 25047-754-01, view more
    25047-755-01
  • Packager: DMG AMERICA, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated October 1, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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 - 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
  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!