ORAJEL TOOTHACHE STRIPS- benzocaine, menthol strip 
Church & Dwight Co., Inc.

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 physician 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

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

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-99886-02

ORAJEL  TOOTHACHE STRIPS
benzocaine, menthol strip
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-776
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE150 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-776-011 in 1 CARTON01/15/201903/31/2023
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 finalpart35611/05/201803/31/2023
Labeler - Church & Dwight Co., Inc. (001211952)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Biofilm734555951manufacture(10237-776)

Revised: 8/2020
 
Church & Dwight Co., Inc.