Your browser does not support JavaScript! CUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]
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CUTIECAINE (topical lidocaine (5% w/w)) cream
[Transdermal Corp]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Cutiecaine-5%, Topical Lidocaine Cream (5% 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

for relief of pain and discomfort from; hemorrhoids pain and Itching, Other Uses; minor cuts, bruises, sun burn, insect bites, poison ivy, etc.

Use for reducing pain or discomfort from;  hemorrhoids pain and Itching. minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy,  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

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

Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,SDS, 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 (5% w/w) cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51350-111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER HOMOPOLYMER TYPE C 
GLYCERIN 
STEARIC ACID 
SODIUM LAURYL SULFATE 
ISOPROPYL ALCOHOL 
CETYL ALCOHOL 
ALCOHOL 
ALOE  
HYALURONATE SODIUM 
POLYSORBATE 20 
BUTYLENE GLYCOL 
CASTOR OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51350-111-021 in 1 CARTON
1NDC:51350-111-0115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/15/2011
Labeler - Transdermal Corp (963383612)
Registrant - Transdermal Corp (963383612)
Establishment
NameAddressID/FEIBusiness Operations
Transdermal Corp963383612manufacture, label, analysis, pack

Revised: 11/2011
 
Transdermal Corp

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