ORAJEL- benzocaine strip 
BioFilm

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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Orajel Toothache Strips

Benzocaine 15 mg

Menthol 2.5 mg

Benzocaine - Oral Pain Reliever

Menthol - Oral Pain Reliever

Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried to the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatique or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider • for teething • in children under 12 years of age

Stop use and ask a phyisican if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions • make sure hands are dry and free of moisture as strip may be sticky/tacky • tear open pouch and remove blue strip

Adults and children 12 years or age and over: Using either side of strip, immediately place directly onto the affected area keeping tongue and lips clear. Gently press for 5-10 seconds until strip adheres to the area. Strip will stay in place and dissolve slowly in mouth for up to 1 hour for duration of treatment. Use up to 4 times daily or as directed by a physician or healthcare provider.

Children under 12 years of age: Do not use

Other Information • do not use if pouch is torn or cut prior to opening • do not use continously • for best results, avoid drinking warm beverages or eating for at least one hour after applying the product

acid blue 9, glycerin, PEG-8, PEG-90, polycarbophil, potassium sorbate, pullulan, PVP, titanium dioxide, water.

Questions • call us at 800 952 5080 Monday through Friday 9am to 5pm or visit our website at www orajel com

#1 ORAL PAIN

Reliever Brand

For Toothache

NEW!

SLOW DISSOLVING STRIPS

For Lasting Relief

Orajel™

TOOTHACHE STRIPS

MEDICATED FOR TOOTHACHE & GUM

INSTANT & TARGETED PAIN RELIEF

• Long-Lasting Pain Relief

•Maximum level of Pain Relief with 15mg Benzocaine*

•Stays in place for Targeted Relief

•Soothes gums with Menthol

Cool Mint Taste

8 STRIPS

Individually Wrapped

Oral Pain Reliever

OJFC-9986-01.jpg

ORAJEL 
benzocaine strip
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72337-776
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
POLYCARBOPHIL (UNII: W25LM17A4W)  
ACID BLUE 9 AMMONIUM (UNII: 86R7G3C26F)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72337-776-011 in 1 CARTON01/15/2019
18 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/05/2018
Labeler - BioFilm (734555951)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
BioFilm734555951manufacture(72337-776)

Revised: 1/2020
Document Id: 9cbd5bda-f953-1914-e053-2995a90afd6b
Set id: 71d7e8b7-a059-7843-e053-2a95a90affde
Version: 4
Effective Time: 20200122
 
BioFilm