CURACAINE- lidocaine cream 
Transdermal Corp

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.

----------

Active Ingredients

Lidocaine 4%

PURPOSE:

topical analgesic

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses for the temporary relief of

  • pain and itching
  • insect bites
  • sunburn
  • minor cuts
  • scrapes
  • burns
  • minor skin irritations

Warnings

For external use only

When using this product

  • Keep out of eyes. Rinse with water to remove.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • If pregnant or breast feeding, ask a health professional before use.

Directions

Adults and children 2 years of age and older:

Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Inactive Ingredients

Caprylyl Glycol, Cetearyl Alcohol, Clyclopentasiloxane, Deionized water, Dimethyl Sulone, Glycerin, Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Polysorbate 60, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium hyaluronate, Sodium Lauryl Sulfate, Stearic Acid, Tetrasodium EDTA, Tocopheryl Acetate

Stop use and ask a doctor if conditions worsens, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of the product and consult a doctor.

Curacaine Box_Front

Curacaine Box_Back

Curacaine Tube

CURACAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51350-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
JOJOBA OIL (UNII: 724GKU717M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51350-011-511 in 1 BOX
1NDC:51350-011-0130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/03/2015
Labeler - Transdermal Corp (963383612)
Registrant - Transdermal Corp (963383612)

Revised: 4/2015
Document Id: 2e03cdce-9668-41b3-9d88-95cfa038f581
Set id: 731c9dc1-9b77-4d10-9851-d35eb777f7cd
Version: 2
Effective Time: 20150415
 
Transdermal Corp