REG- lidocaine hydrochloride gel 
TG Ventureprises 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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Numb Gel 5%

Numb Gel 5.0%

Numb Gel

REG 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73663-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 4 g  in 100 g
CUCUMBER JUICE (UNII: 61845009SP) 0.1 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E) 2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
CAFFEINE (UNII: 3G6A5W338E) 0.25 g  in 100 g
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR) 5 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.2 g  in 100 g
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73663-001-04120 g in 1 JAR; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34810/01/2020
Labeler - TG Ventureprises LLC (117373103)
Establishment
NameAddressID/FEIBusiness Operations
Debut Development LLC079705544manufacture(73663-001)

Revised: 7/2020
Document Id: a9bc4b97-17ce-56cf-e053-2995a90aed2d
Set id: a9bc4b97-17cd-56cf-e053-2995a90aed2d
Version: 1
Effective Time: 20200705
 
TG Ventureprises LLC