ANESTHETIC- lidocaine hydrochloride benzocaine gel 
COSMOCEUTICAL RESEARCH CENTER INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ANESTHETIC GEL

USES: FOR THE TEMPORARY RELIEF OF PAIN.

INACTIVE INGREDIENTS: WATER, ETHOXYDIGLYCOL, TROLAMINE, CARBOMER, ALLANTOIN, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, ETHYL AMINOBENZOATE.

RX ONLY

CRC

ANESTHETIC GEL

NDC: 66538-301-15

1/2 OZ. (15 ML)

Anesthetic Gel Label 001

ANESTHETIC 
lidocaine hydrochloride benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66538-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ALLANTOIN (UNII: 344S277G0Z)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
BENZOCAINE (UNII: U3RSY48JW5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66538-301-1515 g in 1 BOTTLE; Type 0: Not a Combination Product02/18/201202/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/18/201202/05/2019
Labeler - COSMOCEUTICAL RESEARCH CENTER INC (160019006)
Registrant - COSMOCEUTICAL RESEARCH CENTER INC (160019006)
Establishment
NameAddressID/FEIBusiness Operations
COSMOCEUTICAL RESEARCH CENTER INC160019006manufacture(66538-301)

Revised: 2/2019
Document Id: c3fadfee-8d8d-44b1-b06e-922c4a73dca0
Set id: 0dd8628f-1fca-4993-adc8-e1e64f2ae39d
Version: 6
Effective Time: 20190207
 
COSMOCEUTICAL RESEARCH CENTER INC