Orajel 3x Medicated For Toothache And Gum, Gel

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Water Polyethylene Glycol 400 Methyl Salicylate Saccharin Glycyrrhizin Peg-75 Lanolin Sorbic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-11-01

Medication Information

Warnings and Precautions

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

Description

Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Use

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

Section 50565-1

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

Section 50570-1

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 51727-6

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

Section 51945-4

#1 ORAL PAIN

RELIEF BRAND

FOR ADULTS

EXTRA

STRENGTH

Orajel™

3X TOOTHACHE & GUM

MEDICATED

IMMEDIATE PAIN RELIEF

ORAL PAIN

RELIEVER/

ASTRINGENT

Provides

Long-Lasting

Pain Relief*

Soothes

Irritated Gums

Delivers Targeted

Pain Relief

GEL

NET WT

0.25 OZ (7.0 g)

Section 55105-1

Oral pain reliever and Oral astringent

Section 55106-9

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Directions

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 Tamper-Evident Tab is open before first use

Questions Or Comments?

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

Stop Use and Ask A Doctor If

symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persists or worsens

Structured Label Content

Use

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

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

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 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

#1 ORAL PAIN

RELIEF BRAND

FOR ADULTS

EXTRA

STRENGTH

Orajel™

3X TOOTHACHE & GUM

MEDICATED

IMMEDIATE PAIN RELIEF

ORAL PAIN

RELIEVER/

ASTRINGENT

Provides

Long-Lasting

Pain Relief*

Soothes

Irritated Gums

Delivers Targeted

Pain Relief

GEL

NET WT

0.25 OZ (7.0 g)

Section 55105-1 (55105-1)

Oral pain reliever and Oral astringent

Section 55106-9 (55106-9)

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Directions

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 (Other information)

do not use if Tamper-Evident Tab is open before first use

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persists or worsens

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Orajel 3x Medicated For Toothache And Gum, Gel

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information