Label: SCOTTS SELECT TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 69638-060-32, 69638-061-32, 69638-062-32, 69638-063-32, view more
    69638-064-32, 69638-065-32
  • Packager: Scott's Dental Supply 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 April 25, 2023

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  • SPL UNCLASSIFIED SECTION

    MINT
    Drug Facts

  • Active Ingredients

    Benzocaine, 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental procedures.

  • Warnings

    Allergy Alert

    Do Not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

    Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    Do not exceed recommended dosage.

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Green #3, FD&C Yellow #5, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.

  • SPL UNCLASSIFIED SECTION

    CHERRY
    Drug Facts

  • Active Ingredients

    Benzocaine, 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental proceedures.

  • Warnings

    Allergy alert

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

    Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    Do not exceed recommended dosage.

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of the product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    Store at room temperature 59-86 °F (15-30 °C). Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Red #40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.

  • SPL UNCLASSIFIED SECTION

    STRAWBERRY
    Drug Facts

  • Active Ingredients

    Benzocaine, 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental proceedures.

  • Warnings

    Allergy Alert

    Do Not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

    Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    Do not exceed recommended dosage.

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Red # 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.

  • SPL UNCLASSIFIED SECTION

    PINA COLADA
    Drug Facts

  • Active Ingredients

    Benzocaine, 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental procedures.

  • Warnings

    Allergy Alert

    Do Not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

    Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    Do not exceed recommended dosage.

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Red # 40, FD&C Blue # 1, FD&C Yellow # 6, FD&C Yellow # 5, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.

  • SPL UNCLASSIFIED SECTION

    BUBBLE GUM
    Drug Facts

  • Active Ingredients

    Benzocaine, 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental procedures.

  • Warnings

    Allergy Alert

    Do Not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

    Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    Do not exceed recommended dosage.

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Red # 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.

  • SPL UNCLASSIFIED SECTION

    RASPBERRY
    Drug Facts

  • Active Ingredients

    Benzocaine, 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental procedures.

  • Warnings

    Allergy Alert

    Do Not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

    Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    Do not exceed recommended dosage.

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Red # 40, FD&C Blue # 1, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.

  • PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - MINT

    Scott's
    SELECT ✓

    TOPICAL ANESTHETIC GEL
    With Vitamin E and Xylitol • Gluten Free

    REORDER 972-4402

    1.12 OZ (32g)

    MINT

    Peel Here

    PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - MINT
  • PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - CHERRY

    Scott's
    SELECT ✓

    TOPICAL ANESTHETIC GEL
    With Vitamin E and Xylitol • Gluten Free

    REORDER 972-4401

    1.12 OZ (32g)

    CHERRY

    Peel Here

    PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - CHERRY
  • PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - STRAWBERRY

    Scott's
    SELECT ✓

    TOPICAL ANESTHETIC GEL
    With Vitamin E and Xylitol • Gluten Free

    REORDER 972-4403

    1.12 OZ (32g)

    STRAWBERRY

    Peel Here

    Principal Display Panel - 32 g Bottle Label - STRAWBERRY
  • PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - PINA COLADA

    Scott's
    SELECT ✓
    TOPICAL ANESTHETIC GEL

    With Vitamin E and Xylitol • Gluten Free

    REORDER 972-4404

    1.12 OZ (32g)

    PIÑA COLADA

    Peel Here

    PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - PINA COLADA
  • PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - BUBBLE GUM

    Scott's
    SELECT ✓

    TOPICAL ANESTHETIC GEL
    With Vitamin E and Xylitol • Gluten Free

    REORDER 972-4405

    1.12 OZ (32g)

    BUBBLE GUM

    Peel Here

    PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - BUBBLE GUM
  • PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - RASPBERRY

    Scott's
    SELECT ✓

    TOPICAL ANESTHETIC GEL
    With Vitamin E and Xylitol • Gluten Free

    REORDER 972-4406

    1.12 OZ (32g)

    RASPBERRY

    Peel Here

    PRINCIPAL DISPLAY PANEL - 32 g Bottle Label - RASPBERRY
  • INGREDIENTS AND APPEARANCE
    SCOTTS SELECT TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69638-063
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-063-3232 g in 1 BOTTLE; Type 0: Not a Combination Product07/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/20/2017
    SCOTTS SELECT TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69638-061
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-061-3232 g in 1 BOTTLE; Type 0: Not a Combination Product07/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/23/2017
    SCOTTS SELECT TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69638-065
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-065-3232 g in 1 BOTTLE; Type 0: Not a Combination Product07/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/23/2017
    SCOTTS SELECT TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69638-062
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPINEAPPLE (PINA COLADA) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-062-3232 g in 1 BOTTLE; Type 0: Not a Combination Product07/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/23/2017
    SCOTTS SELECT TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69638-060
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-060-3232 g in 1 BOTTLE; Type 0: Not a Combination Product07/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/23/2017
    SCOTTS SELECT TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69638-064
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69638-064-3232 g in 1 BOTTLE; Type 0: Not a Combination Product07/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/23/2017
    Labeler - Scott's Dental Supply LLC (137217043)
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