Label: NEUTRACAINE- benzocaine hydrochloride powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 49939-201-01 - Packager: Invado Pharmaceuticals, LLC
- 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 7, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each packet)
- Purpose
- Uses
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Warnings
This product contains benzocaine. The use of benzocaine applied to the mouth or gums has been associated with methemoglobinemia (a condition where the amount of oxygen in the blood stream is reduced).
Stop using
immediately if you experience any of the following symptoms and seek medical attention:
- Pale, gray or blue colored skin, lips, or nail beds
- Headache or lightheadedness
Ask a doctor if:
- Sore mouth symptoms do not improve in 7 days
- Irritation, pain or swelling persists or worsens
- Pale, gray or blue colored skin, lips, or nail beds
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Directions
Dissolve one packet of NeutraCaine® in a clean glass of 30 mL (1 ounce) of tap water. Distilled, bottled or purified water can also be used. Use immediately after the solution appears clear or nearly clear in the glass, or in about 15 seconds. Stir if necessary
(1) Swish 1/2 the solution in the mouth for 1 min and spit out.
(2) Repeat with the remaining 1/2 of the solution and spit outAdults and children 12 years and over Use NeutraCaine up to 4 times per day, as needed;
Do not exceed recommended dosageChildren under 12 years of age Use NeutraCaine up to 4 times per day, as needed;
Should be supervised by an adult;
Do not exceed recommended dosage
Children under 2 years Ask a doctor or dentist - Other information
- Inactive ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
NEUTRACAINE
benzocaine hydrochloride powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49939-201 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE HYDROCHLORIDE (UNII: OG625Z9LEO) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE HYDROCHLORIDE 90 mg Inactive Ingredients Ingredient Name Strength CALCIUM CHLORIDE (UNII: M4I0D6VV5M) SODIUM PHOSPHATE (UNII: SE337SVY37) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49939-201-01 30 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 03/07/2014 Labeler - Invado Pharmaceuticals, LLC (831722199)
