Label: TOPICALE- benzocaine gel

  • NDC Code(s): 10733-167-43, 10733-169-43, 10733-170-43, 10733-171-43
  • Packager: Medical Products Laboratories, Inc.
  • 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 July 25, 2023

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  • Active Ingredient

    Benzocaine 18%

  • PURPOSE

    Oral Anesthetic

  • INDICATIONS & USAGE

    For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances​

  • 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, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy.

    • Do not use for Teething
    • Do not use in children under 2 years of age
    • Do not use in large quantities or over large areas of body

    Allergy Alert:

    Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics

    When using this product

    • Avoid contact with eyes

    In case of accidental overdose, get medical help or contact a Poison Control Centre immediately

    Stop use and ask a doctor

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting
    If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens

  • DOSAGE & ADMINISTRATION

    • Do not use more than directed.

    Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor.

    Children 2-12 years of age - Should be supervised in the use of the product

    Children under 2 years of age - Do not use

  • OTHER SAFETY INFORMATION

    • Do not use if imprinted seal under cap is broken or missing

    • Store at 68º to 77º F (20º - 25º C)
  • INACTIVE INGREDIENT

    Benzalkonium Chloride (as a preservative), Carbomers, D&C Red Dye # 33 (Cherry & Raspberry), FD&C Red Dye # 40 (Strawberry), Flavorings, Polyethylene glycol, Purified Water, Saccharin sodium.

  • INFORMATION FOR OWNERS/CAREGIVERS

    Premier

    Topicale

    Topical Anestheic Gel

    REF

    9007141 Cherry

    9007142 Raspberry

    9007143 Strawberry

    9007144 Pina Colada

    9007140 Assorted

    Made in U.S.A.

    Contents: Three 43g Pumps

    0518001 Rev4 MPL 317935

    Retain drug facts for future reference.​

    Manufactured for: Premier® Dental Products Company,

    1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.

    Manufacturer: Medical Products Laboratories, Inc.

    9990 Global Road Philadelphia, PA 19115 U.S.A.

    Questions or Comments?

    888.670.6100 or 610.239.6000

    M-Th: 7:30a.m. - 5:30p.m., F: 7:30a.m. - 4:00p.m. EST

    To obtain an SDS, contact Customer Service Department or visit www.premusa.com.

  • PRINCIPAL DISPLAY PANEL

    pump labelpump labelpump labelpump labelpackage insert

  • INGREDIENTS AND APPEARANCE
    TOPICALE 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10733-167
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE180 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10733-167-4343 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/05/2019
    TOPICALE 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10733-170
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE180 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOCONUT (Pina Colada) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10733-170-4343 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/05/2019
    TOPICALE 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10733-169
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE180 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10733-169-4343 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/01/2019
    TOPICALE 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10733-171
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE180 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10733-171-4343 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/05/2019
    Labeler - Medical Products Laboratories, Inc. (002290302)
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