SCOTTS SELECT TOPICAL ANESTHETIC- benzocaine gel

Scotts Select Topical Anesthetic by

Drug Labeling and Warnings

Scotts Select Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Scott's Dental Supply LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL - 32 g Bottle Label

Scott's
SELECT ✓

TOPICAL ANESTHETIC GEL
Wtih Vitamin E and Xylitol Gluten Free

REORDER 972-4402

1.12 OZ (32g)

MINT

Peel Here

INGREDIENTS AND APPEARANCE

SCOTTS SELECT TOPICAL ANESTHETIC 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69638-063
Route of Administration	ORAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69638-063-32	32 g in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/20/2017

Labeler - Scott's Dental Supply LLC (137217043)