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Anesthetic Gel: Package Insert / Prescribing Info

Package insert / product label
Generic name: lidocaine hydrochloride
Dosage form: gel
Drug class: Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Mar 25, 2025.

ACTIVE INGREDIENTS:

LIDOCAINE HCL 5.0% W/W

PURPOSE:

PAIN RELIEVER

USES: FOR THE TEMPORARY RELIEF OF PAIN.

WARNINGS: FOR EXTERNAL USE ONLY.
TO BE USED UNDER MEDICAL SUPERVISION ONLY.

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

KEEP OUT OF REACH OF CHILDREN.

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 HYDROCHLORIDE5 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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/18/2012
Labeler - COSMOCEUTICAL RESEARCH CENTER INC (160019006)
Registrant - COSMOCEUTICAL RESEARCH CENTER INC (160019006)
Establishment
NameAddressID/FEIBusiness Operations
COSMOCEUTICAL RESEARCH CENTER INC160019006manufacture

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