SCOTTS SELECT TOPICAL ANESTHETIC- benzocaine gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benzocaine, 20%

Available from:

Scott's Dental Supply LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

SCOTTS SELECT TOPICAL ANESTHETIC- BENZOCAINE GEL
SCOTT'S DENTAL SUPPLY LLC
_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
DRUG FACTS
ACTIVE INGREDIENTS
Benzocaine, 20%
PURPOS E
Oral Anesthetic
US ES
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.
PRINCIPAL DISPLAY PANEL - 32 G BOTTLE LABEL
Scott's
SELECT
TOPICAL ANESTHETIC GEL
With Vitamin E and Xylitol • Gluten Free
REORDER 972-4405
1.12 OZ (32g)
BUBBLE GUM
Peel Here
SCOTTS SELECT TOPICAL ANESTHETIC
benzocaine gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 6 38 -0 6 0
ROUTE OF ADMINISTRATION
ORAL, DENTAL
Scott's Dental Supply LLC
ACTIVE INGREDIE