ZAPOTOL DENTIDOL ORAL ANALGESIC- benzocaine, and benzalkonium chloride gel 
Productos Zapotol Corp.

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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Active ingredients                                                                  Purpose

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

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

Uses

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

Stop use and ask a dentist or doctor if

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

Directions

Other information

Inactive ingredients

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

Distributed by:

Productos Zapotol Corp.

Palmdale, CA 93550

Made in Korea

image description

ZAPOTOL DENTIDOL ORAL ANALGESIC 
benzocaine, and benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59428-500-421 in 1 PACKAGE11/01/2016
111.9 g in 1 CARTON; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/18/2015
Labeler - Productos Zapotol Corp. (186063850)

Revised: 11/2016
Document Id: c8332db3-9bef-41d6-b5f7-2a8584f0ee7b
Set id: 1368d8bd-4263-4d8f-8a44-20571a8d6f8c
Version: 2
Effective Time: 20161101
 
Productos Zapotol Corp.