Curacaine
FDA Label NDC 51350-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Transdermal Corp for the product Curacaine (NDC 51350-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

LIDOCAINE HCL 4%

Otc - Purpose

PURPOSE:

topical analgesic

Otc - Keep Out Of Reach Of Children

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

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

Indications & Usage

Uses for the temporary relief of

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

Warnings

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.

Dosage & Administration

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 Ingredient

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.

Otc - Stop Use

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.

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.

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.

Otc - 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.

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