MEIJER MAXIMUM STRENGTH ORAL PAIN RELIEF- benzocaine, and benzalkonium chloride gel 
MEIJER DISTRIBUTION INC

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

Use

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 physician 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

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Made in Korea

image description

MEIJER MAXIMUM STRENGTH ORAL PAIN RELIEF 
benzocaine, and benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-782
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 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:41250-782-421 in 1 BOX12/08/2016
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 not finalpart35612/08/2016
Labeler - MEIJER DISTRIBUTION INC (006959555)

Revised: 12/2016
Document Id: 611508fa-29c3-435d-b8c4-b2c4bfb0ae8e
Set id: db38f8be-56e1-4e5d-a565-dee523dd1a8b
Version: 1
Effective Time: 20161208
 
MEIJER DISTRIBUTION INC