ORAJEL 3X MEDICATED FOR ALL MOUTH SORES- benzocaine, menthol, zinc chloride gel 
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 3X Medicated For All Mouth Sores, Gel

Benzocaine 20%

Menthol 0.1%

Zinc Chloride 0.15%

Oral pain reliever and Oral astringent

Use

for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

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 in 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, 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

Stop use and ask a doctor if

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

Adults and children 2 years of age and overApply to affected area up to 4 times daily or as directed by a dentist or doctor
Children between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this product
Children under 2 years of ageDo not use

Other information

do not use if Tamper-Evident Tab is open before first use

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

Questions or comments?

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

#1 ORAL PAIN

RELIEF BRAND

FOR ADULTS

EXTRA STRENGTH

Orajel™

3X MOUTH SORES

MEDICATED

IMMEDIATE PAIN RELIEF

ORAL PAIN

RELIEVER/

ASTRINGENT

Provides

Long-Lasting

Pain Relief*

Helps Protect Sores

from Irritation

Delivers Targeted

Pain Relief

GEL

NET WT

0.18 OZ (5.1 g)

Orajel 3x Gel - 31840.jpg

ORAJEL 3X MEDICATED FOR ALL MOUTH SORES 
benzocaine, menthol, zinc chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-783
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
POVIDONE (UNII: FZ989GH94E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBIC ACID (UNII: X045WJ989B)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ALLANTOIN (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-783-181 in 1 PACKAGE11/01/2019
11.8 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10237-783-421 in 1 PACKAGE11/01/2019
24.2 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:10237-783-121 in 1 PACKAGE11/01/2019
33.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-783)

Revised: 1/2022
Document Id: d57d751d-7782-5b70-e053-2995a90a0934
Set id: 99b589ac-9833-fb60-e053-2995a90a0935
Version: 3
Effective Time: 20220113
 
Church & Dwight Co., Inc.