ZAPOTOL DENTIDOL ORAL ANALGESIC- benzocaine, and benzalkonium chloride gel

Zapotol Dentidol Oral Analgesic by

Drug Labeling and Warnings

Zapotol Dentidol Oral Analgesic by is a Otc medication manufactured, distributed, or labeled by Productos Zapotol Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                  Purpose

Benzocaine 20%.................................................................. Oral pain reliever

Benzalkonium chloride 0.1%................................................. Antiseptic

PURPOSE

Uses

• temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances.
• to help protect against infection in minor oral irritation.

WARNINGS

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

Do not use

• more than directed
• for more than 7 days unless directed by a doctor/dentist

STOP USE

Stop use and ask a dentist or doctor if

• swelling, rash, or fever develops
• irritation, pain, or redness persists or worsens
• symptoms do not improve in 7 days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• remove cap and cut tip of tube on score mark
• adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by doctor or dentist.
• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: ask a doctor/dentist

STORAGE AND HANDLING

Other information

• store at 15°-25°C (59°-77°F)
• do not use if tube tip is cut prior to opening
• this preparation is intended for use in cases of toothaches, only as temporary expedient until a dentist can be consulted.
• do not use continuously
• Lot No. & Exp Date: see crimp of tube.

INACTIVE INGREDIENT

Inactive ingredients

glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DOSAGE & ADMINISTRATION

Distributed by:

Productos Zapotol Corp.

Palmdale, CA 93550

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAPOTOL DENTIDOL ORAL ANALGESIC 
benzocaine, and benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59428-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59428-500-42	1 in 1 PACKAGE	11/01/2016
1		11.9 g in 1 CARTON; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/18/2015

Labeler - Productos Zapotol Corp. (186063850)