Label: CUTIECAINE (topical lidocaine- 5% w/w cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51350-111-01, 51350-111-02 - Packager: Transdermal Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated November 15, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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. 15gfor 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
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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
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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
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INGREDIENTS AND APPEARANCE
CUTIECAINE
topical lidocaine (5% w/w) creamProduct 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
