FAMILY WELLNESS REGULAR- benzocaine 10% gel 
Velocity Pharma 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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Family wellness oral pain relief gel

Active ingredient

Benzocaine 10%

Purpose

Oral pain reliever

Use

Warnings

Methemoglobinemla: see package warning.

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 - cut open tip of tube on score mark

Other information

Inactive ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

gel1gel2

FAMILY WELLNESS  REGULAR
benzocaine 10% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-607
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-607-331 in 1 PACKAGE07/02/2020
19 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 finalpart35607/02/2020
Labeler - Velocity Pharma LLC (962198409)

Revised: 7/2020
Document Id: a97a043f-6e8e-666a-e053-2995a90a3d89
Set id: a97a6682-49ec-477c-e053-2a95a90a0bec
Version: 1
Effective Time: 20200702
 
Velocity Pharma LLC