NEUTRACAINE- benzocaine hydrochloride powder, for solution 
Invado Pharmaceuticals, LLC

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.

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NeutraCaine

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

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

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
NEUTRACAINE 
benzocaine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49939-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE HYDROCHLORIDE (UNII: OG625Z9LEO) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE HYDROCHLORIDE90 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49939-201-0130 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35603/07/2014
Labeler - Invado Pharmaceuticals, LLC (831722199)

Revised: 4/2014
Document Id: bd5cc995-1925-4260-8999-6ea8cac811f7
Set id: 3469ec91-abf1-41c7-b67c-46335e9cbd70
Version: 3
Effective Time: 20140407
 
Invado Pharmaceuticals, LLC