CUTIECAINE (topical lidocaine- 4% w/w cream

Cutiecaine by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

DO NOT USE

    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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

CUTIECAINE 
topical lidocaine (4% w/w) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50876-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	180 mg  in 1 g
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	20 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: 50876-182-02	1 in 1 BOX
1	NDC: 50876-182-01	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	08/31/2010

Labeler - Innovatech Inc (833205961)

Registrant - Innovatech Inc (833205961)

Establishment
Name	Address	ID/FEI	Business Operations
Innovatech Inc		833205961	manufacture, label, analysis, pack