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| Product NDC Code | 69638-060 | ||||
|---|---|---|---|---|---|
| Drug Name | Scotts select topical anesthetic |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | DENTAL, ORAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 238910 | ||||
| Application Number | part356 | ||||
| Labeler Name | Scott's Dental Supply LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Benzocaine, 20%
Active Ingredients Benzocaine, 20%
Active Ingredients Benzocaine, 20%
Active Ingredients Benzocaine, 20%
Active Ingredients Benzocaine, 20%
Active Ingredients Benzocaine, 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
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.
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.
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.
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.
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients FD&C Green #3, FD&C Yellow #5, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.
Inactive Ingredients FD&C Red #40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.
Inactive Ingredients FD&C Red # 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.
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.
Inactive Ingredients FD&C Red # 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.
Inactive Ingredients FD&C Red # 40, FD&C Blue # 1, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Uses For the temporary relief of pain associated with canker sores and minor dental proceedures.
Uses For the temporary relief of pain associated with canker sores and minor dental proceedures.
Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic
Purpose Oral Anesthetic
Purpose Oral Anesthetic
Purpose Oral Anesthetic
Purpose Oral Anesthetic
Purpose Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Scotts Select Topical Anesthetic Benzocaine Benzocaine Benzocaine FD&C GREEN NO. 3 FD&C YELLOW NO. 5 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL Scotts Select Topical Anesthetic Benzocaine Benzocaine Benzocaine FD&C RED NO. 40 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL Scotts Select Topical Anesthetic Benzocaine Benzocaine Benzocaine FD&C RED NO. 40 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL Scotts Select Topical Anesthetic Benzocaine Benzocaine Benzocaine FD&C RED NO. 40 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL PINA COLADA Scotts Select Topical Anesthetic Benzocaine Benzocaine Benzocaine FD&C RED NO. 40 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL Scotts Select Topical Anesthetic Benzocaine Benzocaine Benzocaine FD&C RED NO. 40 FD&C BLUE NO. 1 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.MINT Drug Facts
CHERRY Drug Facts
STRAWBERRY Drug Facts
PINA COLADA Drug Facts
BUBBLE GUM Drug Facts
RASPBERRY Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
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.
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.
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.
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.
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
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
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.
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.
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.
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.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.
Other Information Store at room temperature 59-86 °F (15-30 °C). Protect from freezing and heat.
Other Information Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.
Other Information Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.
Other Information Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.
Other Information Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
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.
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.
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.
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.
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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API