ORAJEL RESCUE RELIEF PEN- oral pain reliever gel

Orajel Rescue Relief Pen by

Drug Labeling and Warnings

Orajel Rescue Relief Pen by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Benzocaine 20%
Menthol 0.26%

Zinc chloride 0.15%

PURPOSE

Oral Pain Reliever / Oral Astringent

USES

for the temporary relief of
pain due to minor irritation or injury of the mouth and gums
occasional sore mouth and sore throat

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

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 DENTIST OR DOCTOR IF

sore throat is severe, persists for more than 2 days

sore mouth symptoms do not improve in 7 days

headache, nausea, vomiting, swelling, rash or fever develops

irritation, pain or redness persists or worsens

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: apply to the 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 package has been opened

INACTIVE INGREDIENTS

ammonium glycrrhizate, 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

RELIEF BRAND

FOR ADULTS

Orajel™

TOOTHACHE & GUM

IMMEDIATE RELIEF OF:

ORAL PAIN

BRACE/DENTURE IRRITATION

GUM DISCOMFORT

CANKER SORES

RESCUE RELIEF PEN

GENTLE. TARGETED. TOUCH-FREE.

PLUS COOLING RELIEF

50+ USES

ORAL PAIN RELIEVER / ASTRINGENT

NET WT 0.07 OZ (2.0 g)

INGREDIENTS AND APPEARANCE

ORAJEL RESCUE RELIEF PEN 
oral pain reliever gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-731
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SORBIC ACID (UNII: X045WJ989B)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEG-75 (UNII: G2M7P15E5P)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (Pale yellow to tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-731-07	1 in 1 BLISTER PACK	02/01/2025
1		2 g in 1 APPLICATOR; 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	02/01/2025

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