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CURACAINE by Transdermal Corp

Medically reviewed on February 14, 2017

Dosage form: cream
Ingredients: LIDOCAINE HYDROCHLORIDE 4g in 100mL
Labeler: Transdermal Corp
NDC Code: 51350-012

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 HCL 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.

PURPOSE

TOPICAL ANALGESIC

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 UANTITIES, PARTICULARLY OVER RAW SURFACES OR BLISTERED AREAS.

STOP USE AND ASK A DOCTOR IF CONDITION WORSENS, OR, IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A PISON CONTROL CENTER RIGHT AWAY.

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.

OTHER INFORMATION
  • STORE BETWEEN 58° - 87° F.
  • PROTECT FROM FREEZING, DIRECT HEAT OR SUNLIGHT.

QUESTIONS?

CALL 248.341.3401 9AM-2PM CENTRAL

INACTIVE INGREDIENTS:

CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, DEIONIZED WATER, DIMETHYL SULFONE, GLYCERIN, HEXYLENE GLYCOL, PHENOXYETHANOL, POLYSORBATE 20, POLYSORBATE 60, PROPYLENE GLYCOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, STEARIC ACID, TETRASODIUM EDTA, TOCOPHERYL ACETATE.

CURACAINE 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51350-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 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 Description
1NDC:51350-012-511 TUBE in 1 BOX
1NDC:51350-012-1130 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)

 
Transdermal Corp

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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