Label: CURACAINE- lidocaine cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 51350-011-01, 51350-011-51 - 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 April 15, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CURACAINE
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51350-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:51350-011-51 1 in 1 BOX 1 NDC:51350-011-01 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/03/2015 Labeler - Transdermal Corp (963383612) Registrant - Transdermal Corp (963383612)
