FDA Label for Curacaine
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- OTC - PURPOSE
- OTC - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTC - STOP USE
- PURPOSE
- USES:
- WARNINGS:
- WHEN USING THIS PRODUCT
- OTC - PREGNANCY OR BREAST FEEDING
- DIRECTIONS:
- OTHER INFORMATION
- QUESTIONS?
- INACTIVE INGREDIENTS:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Curacaine Product Label
The following document was submitted to the FDA by the labeler of this product Transdermal Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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