LEADER ORAL ANALGESIC- benzocaine gel 
CARDINAL HEALTH

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 ingredient                                                                Purpose

Benzocaine 20%................................................................Oral Pain Reliever

Uses

Warnings

Allergy alert: do not use this product if you have a history of allergic to local anesthetics such as procaine, butacaine, benzocaine, or other caine anesthetics

Do not use

Stop use and ask a 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

d-sorbitol solution, flavor, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium hydrate

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea

image description

LEADER ORAL ANALGESIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-122-121 in 1 CARTON10/11/2016
111.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/01/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 7/2017
Document Id: d79aee73-493f-4cd8-811b-758fb81db928
Set id: 26875610-8552-4e41-a4fe-7710a4a93846
Version: 3
Effective Time: 20170707
 
CARDINAL HEALTH