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.

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Drug Facts

Benzocaine 18% (w/w), Tetracaine 2% (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 not 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.

Keep both used and unused medicine out of the reach of children or pets

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.

 Do not use in or near the eyes
•    Do not 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.

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

Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil, sodium lauryl sulfate,

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

carton.jpg
image of carton label
CUTIECAINE 
topical lidocaine (4% w/w) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50876-182
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE180 mg  in 1 g
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE20 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:50876-182-021 in 1 BOX
1NDC:50876-182-0115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2010
Labeler - Innovatech Inc (833205961)
Registrant - Innovatech Inc (833205961)
Establishment
NameAddressID/FEIBusiness Operations
Innovatech Inc 833205961manufacture, label, analysis, pack

Revised: 4/2011
Document Id: e7d4de92-2088-42c9-885f-e9845fa16c1d
Set id: f6591163-8a63-4f5e-8845-71809e744d5b
Version: 1
Effective Time: 20110427
 
Innovatech Inc