Label: TOPICAL ANESTHETIC- benzocaine gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 4, 2018

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  • SPL UNCLASSIFIED SECTION

    Gel – 1oz/34g
    2731001 Cherry
    2731002 Mint
    2731004 Pina Colada
    2731005 Bubble Gum
    2731006 Strawberry
    2731007 Raspberry

    For dental use only

    Rx only

  • 1. INDICATIONS AND USAGE

    Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.

  • 2. DOSAGE AND ADMINISTRATION

    Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.
    Tightly re-cap the jar after each use.
  • 3. DOSAGE FORMS AND STRENGTH

    Each gram of 20% Benzocaine Gel contains between 180-220 mg benzocaine in a flavored base.

  • 4. CONTRAINDICATIONS

    Should not be used with individuals with a known sensitivity to benzocaine or PABA.

  • 5. WARNINGS AND PRECAUTIONS

    METHEMOGLOBINEMIA WARNING

    Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:

     •
    pale, gray or blue colored skin (cyanosis)
     •
    headache
     •
    rapid heart rate
     •
    shortness of breath
     •
    dizziness or lightheadedness
     •
    fatigue or lack of energy
    Not for use in children under 2 years of age
    Keep out of reach of children
    For professional dental use only
    Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle
  • 6. OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • 7. DESCRIPTION

    Flavored 20% benzocaine gel for topical mucosa anesthesia

  • 8. HOW SUPPLIED/STORAGE AND HANDLING

    20% benzocaine gel is supplied in multiple use containers

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

  • SPL UNCLASSIFIED SECTION

    For more information call NDC at 1-800-929-4232
    Manufactured for NDC Nashville, TN 37217
    Made in the USA
    2731001DF, R1-120116

  • PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry

    Topical Anesthetic Gel
    20% Benzocaine
    Cherry

    REF: 2731001

    CHERRY

    Quala®
    DENTAL PRODUCTS

    NET CONTENTS:
    1 oz (34g)

    Rx Only
    NDC 43128-021-30

    PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry
  • PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint

    Topical Anesthetic Gel
    20% Benzocaine
    Mint

    REF: 2731002

    MINT

    Quala®
    DENTAL PRODUCTS

    NET CONTENTS:
    1 oz (34g)

    Rx Only
    NDC 43128-023-30

    PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint
  • PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada

    Topical Anesthetic Gel
    20% Benzocaine
    Piña Colada

    REF: 2731004

    PIÑA COLADA

    Quala®
    DENTAL PRODUCTS

    NET CONTENTS:
    1 oz (34g)

    Rx Only
    NDC 43128-024-30

    PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada
  • PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum

    Topical Anesthetic Gel
    20% Benzocaine
    Bubble Gum

    REF: 2731005

    BUBBLE GUM

    Quala®
    DENTAL PRODUCTS

    NET CONTENTS:
    1 oz (34g)

    Rx Only
    NDC 43128-022-30

    PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum
  • PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry

    Topical Anesthetic Gel
    20% Benzocaine
    Strawberry

    REF: 2731006

    STRAWBERRY

    Quala®
    DENTAL PRODUCTS

    NET CONTENTS:
    1 oz (34g)

    Rx Only
    NDC 43128-020-30

    PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry
  • PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry

    Topical Anesthetic Gel
    20% Benzocaine
    Raspberry

    REF: 2731007

    RASPBERRY

    Quala®
    DENTAL PRODUCTS

    NET CONTENTS:
    1 oz (34g)

    Rx Only
    NDC 43128-026-30

    PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry
  • INGREDIENTS AND APPEARANCE
    TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-021
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Water (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43128-021-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-023
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Water (UNII: 059QF0KO0R)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43128-023-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-024
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCOCONUT (Pina Colada) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43128-024-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-022
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Water (UNII: 059QF0KO0R)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43128-022-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-020
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Water (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43128-020-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-026
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Water (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43128-026-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    Labeler - NDC, Inc. (009831413)
    Establishment
    NameAddressID/FEIBusiness Operations
    Caulk083235549MANUFACTURE(43128-021, 43128-023, 43128-024, 43128-022, 43128-020, 43128-026)