CUTIECAINE (topical lidocaine- 5% w/w cream

Cutiecaine by

Drug Labeling and Warnings

Cutiecaine by is a Otc medication manufactured, distributed, or labeled by Transdermal Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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

WARNINGS

    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.

PRINCIPAL DISPLAY PANEL

carton.jpg

INGREDIENTS AND APPEARANCE

CUTIECAINE 
topical lidocaine (5% w/w) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51350-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51350-111-02	1 in 1 CARTON
1	NDC: 51350-111-01	15 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/15/2011

Labeler - Transdermal Corp (963383612)

Registrant - Transdermal Corp (963383612)

Establishment
Name	Address	ID/FEI	Business Operations
Transdermal Corp		963383612	manufacture, label, analysis, pack