ORAJEL 4X MEDICATED PM FOR TOOTHACHE AND GUM- benzalkonium chloride, benzocaine, menthol, zinc chloride cream 
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 4X Medicated PM For Toothache and Gum, Cream

Active Ingredients

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Purpose

Oral antiseptic, Oral pain reliever, Oral astringent

Uses

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

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

Inactive ingredients

ammonium glycyrrhizate, chamomile, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, 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 FOR TOOTHACHES

Ready-Open Tube Tip

Orajel

4X MEDICATED FOR TOOTHACHE AND GUM

NIGHTTIME FORMULA WITH CHAMOMILE

INSTANT PAIN RELIEF CREAM

Clinical Strength Pain Relief

Proven to Kill Harmful Bacteria

Helps Prevent Infection

Cooling Relief for Gum Irritation

ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

NET WT

0.25 OZ (7.0 g)

OJFC-31854-11.jpg

ORAJEL 4X MEDICATED PM FOR TOOTHACHE AND GUM 
benzalkonium chloride, benzocaine, menthol, zinc chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-789
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 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
PEG-75 LANOLIN (UNII: 09179OX7TB)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
CHAMOMILE (UNII: FGL3685T2X)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SORBIC ACID (UNII: X045WJ989B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-789-251 in 1 PACKAGE11/01/2019
12.5 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 FINALpart333A11/01/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812MANUFACTURE(10237-789)

Revised: 1/2023
Document Id: a1ba29b5-e2b7-44cd-a2a5-cbdf292cff18
Set id: 999cff2b-c23e-5abe-e053-2a95a90a7569
Version: 7
Effective Time: 20230110
 
Church & Dwight Co., Inc.