CURACAINE TRANSDERMAL CORPORATION- 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.

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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 Sulfate, Steric Acid, Tetrasodium EDTA, Tocopheryl Acetate, Sodium Hydroxide.

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.

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CURACAINE  TRANSDERMAL CORPORATION
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51350-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL 
CETOSTEARYL ALCOHOL 
CYCLOMETHICONE 5 
GLYCERIN 
HEXYLENE GLYCOL 
PHENOXYETHANOL 
POLYSORBATE 20 
POLYSORBATE 60 
PROPYLENE GLYCOL 
JOJOBA OIL 
HYALURONATE SODIUM 
SODIUM LAURYL SULFATE 
EDETATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51350-010-511 in 1 BOX
1NDC:51350-010-0130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/12/2012
Labeler - Transdermal Corp (963383612)
Registrant - Transdermal Corp (963383612)

Revised: 8/2013
Document Id: 22656e3a-9f61-4cb9-9d8d-e2eb17ca8149
Set id: e4937cce-370b-4a1f-8a0e-3bde77fe146b
Version: 12
Effective Time: 20130815
 
Transdermal Corp