DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (200 mg) Menthol (2.6 mg)

Inactive Ingredients

Polyethylene Glycol 400 Ammonium Glycyrrhizate Sodium Saccharin Polyethylene Glycol 3350 Sorbic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-05-23

Medication Information

Warnings and Precautions

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

Purpose

Oral pain reliever

Description

Benzocaine 20% Menthol 0.26%

Use

for the temporary relief of pain due to toothaches

Section 50565-1

Keep out of reach of children. In case of overdose or allergic reaction, get medical

help or contact a Poison Control Center right away

Section 50566-9

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

Section 50570-1

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

Section 51945-4

#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)

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

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

Active Ingredient

Benzocaine 20%

Menthol 0.26%

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

Structured Label Content

Use (USE)

for the temporary relief of pain due to toothaches

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose or allergic reaction, get medical

help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

#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)

Purpose (PURPOSE)

Oral pain reliever

Warnings (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

Directions (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

Active Ingredient (ACTIVE INGREDIENT)

Benzocaine 20%

Menthol 0.26%

Other Information (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 (Inactive ingredients)

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

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

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIUM GLYCYRRHIZATE", "unii": "3VRD35U26C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM SACCHARIN", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "2.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBIC ACID", "unii": "X045WJ989B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE": "for the temporary relief of pain due to toothaches", "34071-1": "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", "50565-1": "Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away", "50566-9": "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", "50570-1": "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", "51945-4": "#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)", "PURPOSE": "Oral pain reliever", "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", "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", "ACTIVE INGREDIENT": "Benzocaine 20% Menthol 0.26%", "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"}