ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID- benzocaine and menthol liquid 
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 Medicated for Toothache and Gum, Liquid

Benzocaine 20%

Menthol 0.1%

Oral Pain Reliever

Use for the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Methemoglobinemia warning: Use of this product may cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in 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 or breath • dizziness or lightheadedness • fatigue 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

Flammable: keep away from fire or flame. Avoid smoking during application.

Do not use • more than directed • for more than 7 days unless directed by a dentist or doctor •for teething •in children under 2 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

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 • remove imprinted safety seal from bottle cap

Adults and children 2 years of age and over

Children under 12 years of age

Children under 2 years of age

Other Information • do not use if safety seal on bottle cap is broken or missing prior to opening

Inactive Ingredients alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5

Questions or comment? Call us at 800 952 5080 M-F 9am-5pm or visit our website at www orajel.com

#1

ORAL PAIN

RELIEVER BRAND

FOR TOOTHACHE

Fast-Acting Liquid!

Orajel

MEDICATED

FOR TOOTHACHE & GUM

Instant Pain Relief

•20% Benzocaine to Relieve Oral Pain

•Menthol to Soothe Gums

CANKER SORES • CHEEK BITES • DENTURE PAIN

IRRITATION FROM BRACES

ORAL PAIN RELIEVER

0.45 FL OZ (13.3mL)

OJFC-32945-07

ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID 
benzocaine and menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-796
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 g  in 1 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 1 mg
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE (UNII: LAV5U5022Y)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALCOHOL (UNII: 3K9958V90M)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-796-451 in 1 CARTON08/07/2020
113.3 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/07/2020
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac071609663manufacture(10237-796)

Revised: 8/2020
Document Id: ac3d51bf-bd89-5b6b-e053-2a95a90aa3e8
Set id: ac3d605d-241d-1a6f-e053-2a95a90ae391
Version: 1
Effective Time: 20200807
 
Church & Dwight Co., Inc.