SCOTTS SELECT TOPICAL ANESTHETIC- benzocaine gel 
Scott's Dental Supply LLC
Reference Label Set Id: 96e6a5de-7616-44fb-9d78-18968b7e3ee1
Reference Label Set Id: 341c856f-1519-4165-a7fd-4323794012bc
Reference Label Set Id: b42f0d67-6777-42e4-99f8-94d84b409f55
Reference Label Set Id: 933f02a8-aaab-4e7e-945f-644c476ece78
Reference Label Set Id: 6a2c43ec-eb64-4fef-be2c-0294f8b8362e

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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Scott's Select Topical Anesthetic Gel

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

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.

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

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.

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

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.

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

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.

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

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.

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

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
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)

Revised: 4/2023
Document Id: 2fd3a1ff-365b-467b-8f5f-76996c77f34d
Set id: c4188e79-6522-4595-8666-cdc638816a9e
Version: 2
Effective Time: 20230425
 
Scott's Dental Supply LLC