ORAJEL GUM PAIN 3X MEDICATED- 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 Gum Pain 3X Medicated, Gel

Active ingredients

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Purpose

Oral pain reliever and Oral astringent

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 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

Do not use

Do not use

Stop use and ask a doctor if

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

Adults and children 2 years of age and older

Children between 2 and 12 years of age

Children under 2 years of age

Other information

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

Inactive ingredients

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water

Questions or comments?

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

Principal Display Panel

#1 ORAL PAIN

RELIEVER BRAND

FOR ADULTS

Open Tube Tip

Orajel

GUM PAIN

3X MEDICATED GEL

INSTANT PAIN RELIEF

20% Benzocaine to Relieve Gum Pain

Cooling Relief to Soothe Gums

Relieves Gum Irritation

ORAL PAIN RELIEVER/ASTRINGENT

NET WT

0.125oz (3.5g)

CR2_DA2044058_OJFC-00500-01_72016656

ORAJEL GUM PAIN 3X MEDICATED 
benzocaine, menthol, zinc chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-792
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-792-121 in 1 PACKAGE12/17/2019
13.5 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 finalpart34812/17/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-792)

Revised: 1/2023
Document Id: 2ed68d42-3eac-41aa-af15-786c4bf8136f
Set id: 9a1632ad-2b47-5653-e053-2995a90ae0d9
Version: 2
Effective Time: 20230120
 
Church & Dwight Co., Inc.