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Anesthetic Gel

Pronunciation

Generic Name: lidocaine hydrochloride
Dosage Form: gel

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.

Anesthetic Gel

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)

KEEP OUT OF REACH OF CHILDREN.

ANESTHETIC 
lidocaine hydrochloride benzocaine gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66538-301
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
DIETHYLENE GLYCOL MONOETHYL ETHER  
TROLAMINE  
CARBOMER HOMOPOLYMER TYPE C  
ALLANTOIN  
DMDM HYDANTOIN  
IODOPROPYNYL BUTYLCARBAMATE  
BENZOCAINE  
Packaging
# Item Code Package Description
1 NDC:66538-301-15 15 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/18/2012
Labeler - COSMOCEUTICAL RESEARCH CENTER INC (160019006)
Registrant - COSMOCEUTICAL RESEARCH CENTER INC (160019006)
Establishment
Name Address ID/FEI Operations
COSMOCEUTICAL RESEARCH CENTER INC 160019006 manufacture
Revised: 02/2012
 
COSMOCEUTICAL RESEARCH CENTER INC



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