NEUTRACAINE- benzocaine hydrochloride powder, for solution

NeutraCaine by

Drug Labeling and Warnings

NeutraCaine by is a Otc medication manufactured, distributed, or labeled by Invado Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NeutraCaine (Calcium Phosphate Rinse with Benzocaine)

Drug Facts

Active Ingredients (in each packet)

Benzocaine hydrochloride 90 mg (3mg/ml)

Purpose

Analgesic      

Uses

For temporary relief of inflammation and pain in the oral cavity:

* mouth * tongue *cheeks

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

When using this product:

• NeutraCaine® must be mixed with water before use
  
• NeutraCaine® rinse should not be swallowed
  
• NeutraCaine® rinse should be spit out after use

If pregnant or breast feeding, 

ask a health professional before use    

Keep out of reach of children

• If swallowed, immediately call Poison Control Center or doctor.

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 out

• Adults and children 12 years and over: Use NeutraCaine up to 4 times per day, as needed;; Do not exceed recommended dosage
• Children 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

DO NOT USE

FOR MORE THAN 7 DAYS UNLESS DIRECTED BY PHYSICIAN

Other information

• Store at room temperature  ■ Avoid excessive heat or moisture
  
• Do not use if foil packet is opened or shows signs of leakage or damage

Inactive ingredients

Calcium Chloride, Sodium Phosphate, Sodium Chloride, Sodium Bicarbonate, Cherry Flavoring

Manufactured for Invado Pharmaceuticals, LLC
Pomono, NY 10970
Made in Canada
www.NeutraCaine.com 
Patents Pending
UPC Code 793573756282

Package/Label Principal Display Panel

NDC: 49939-201-01
NeutraCaine
(Calcium Phosphate Rinse with Benzocaine)
For relief of oral mucocitis pain
Mix with water before use
30 Packets Dissolving Powder
491 mg per packet | Net wt.14.73g

INGREDIENTS AND APPEARANCE

NEUTRACAINE 
benzocaine hydrochloride powder, for solution

Product 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)