Orajel Rescue Relief Pen

Drug Facts

Composition & Product

Active Ingredients

Zinc Cation (1.5 mg) Menthol (2.6 mg) Benzocaine (200 mg)

Inactive Ingredients

Ammonium Glycyrrhizate Water Sorbic Acid Polyethylene Glycol 400 Peg-75 Sodium Saccharin

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-01

Medication Information

Purpose

Oral Pain Reliever / Oral Astringent

Description

Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Uses

• for the temporary relief of

• pain due to minor irritation or injury of the mouth and gums

• occasional sore mouth and sore throat

Section 51945-4

#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)

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

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

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

Other Information

• do not use if package has been opened

Active Ingredients

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

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

Keep Out of Reach of Children

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

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

Structured Label Content

Uses (USES)

• for the temporary relief of

• pain due to minor irritation or injury of the mouth and gums

• occasional sore mouth and sore throat

Section 51945-4 (51945-4)

#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)

Purpose (PURPOSE)

Oral Pain Reliever / Oral Astringent

Warnings (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

Directions (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

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

Other Information (OTHER INFORMATION)

• do not use if package has been opened

Active Ingredients (ACTIVE INGREDIENTS)

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

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

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.

Stop Use and Ask A Dentist Or Doctor If (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

Advanced Ingredient Data

[{"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "2.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AMMONIUM GLYCYRRHIZATE", "unii": "3VRD35U26C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBIC ACID", "unii": "X045WJ989B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-75", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM SACCHARIN", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "• for the temporary relief of • pain due to minor irritation or injury of the mouth and gums • occasional sore mouth and sore throat", "51945-4": "#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)", "PURPOSE": "Oral Pain Reliever / Oral Astringent", "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", "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", "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", "OTHER INFORMATION": "• do not use if package has been opened", "ACTIVE INGREDIENTS": "Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%", "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", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information