ORAJEL 2X MEDICATED GEL- oral pain reliever gel

Orajel 2X Medicated Gel by

Drug Labeling and Warnings

Orajel 2X Medicated Gel by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

Menthol 0.26%

PURPOSE

Oral pain reliever

USE

for the temporary relief of pain due to toothaches

WARNINGS

Methemogloblnemla 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

WARNINGS

Allergy alert: do not use this product if you have a history of allergy to local
anesthetics such as procaine, butacalne, benzocaine or other "caine" anesthetics

DO NOT USE

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

Stop use and ask a doctor if ■ symptoms do not improve in 7 days ■ swelling, rash
or fever develops ■ irrnation, pain or redness persists or worsens

KEEP OUT OF REACH OF CHILDREN

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

• cut open tip of tube on score mark

Adults and children 2 years of age and over: apply to affected area up to 4 times daily or as directed by a dentist or doctor

Children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product.
Children under 2 years of age: do not use

Other information

■ do not use if tube tip is cut prior to opening ■ this preparation is intended for use in cases of toothache, only as temporary expedient
until a physician can be consulted

Inactive ingredients

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

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 RELIEF BRAND FOR ADULTS

ORAJEL TM

2X TOOTHACHE & GUM MEDICATED

IMMEDIATE PAIN RELIEF

ORAL PAIN RELIEVER

• Soothes Irritated Gums
• Delivers Targeted Pain Relief

GEL

NET WT 0.25 OZ (7.0 g)

INGREDIENTS AND APPEARANCE

ORAJEL 2X MEDICATED GEL 
oral pain reliever gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-782
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-782-25	1 in 1 CARTON	05/23/2022
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	05/23/2022

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-782)