CURACAINE- lidocaine hcl cream

CURACAINE by

Drug Labeling and Warnings

CURACAINE by is a Otc medication manufactured, distributed, or labeled by Transdermal Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

PREGNANCY OR BREAST FEEDING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURACAINE 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51350-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
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)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51350-012-51	1 in 1 BOX	09/12/2012
1	NDC: 51350-012-11	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	09/12/2012

Labeler - Transdermal Corp (963383612)

Registrant - Transdermal Corp (963383612)