CUTIECAINE - topical lidocaine (4% w/w) cream 
Innovatech Inc

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.

----------

Drug Facts

Cutiecaine, Topical Lidocaine Cream (4% w/w),Active Ingredient; Lidocaine Hydrochloride 4% (w/w), Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor

•    Do not use in or near the eyes
•    Do use in large amount particularly over the raw surfaces or blisters
Stop use and Ask Doctors if
•    Allergic reactions occurs
•    Condition worsen and does not improve
•    Symptoms clean up and returns within few day
•    itching, redness, burning , swelling or other symptoms occurs
•    Keep both used and unused medicine out of the reach of children or pets
•    If swallowed get medical attention right away Call your doctor immediately.

carton.jpg
image of carton label
CUTIECAINE 
topical lidocaine (4% w/w) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50876-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE (UNII: V5VD430YW9)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CASTOR OIL (UNII: D5340Y2I9G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50876-111-021 in 1 CARTON
1NDC:50876-111-0115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/31/2010
Labeler - Innovatech Inc (833205961)
Registrant - Innovatech Inc (833205961)
Establishment
NameAddressID/FEIBusiness Operations
Innovatech Inc 833205961manufacture, label, analysis, pack

Revised: 5/2010
Document Id: e52c45c0-5dea-4d96-91c6-ec981065ce13
Set id: e3043645-67fa-4e1b-9a75-b8b908b49756
Version: 1
Effective Time: 20100531
 
Innovatech Inc