Orajel 4x Medicated For Toothache And Gum, Gel
999851ac-925c-7d1f-e053-2a95a90a240b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Belzalkonium chloride 0.13% Benzocaine 20% Menthol 0.5% Zinc chloride 0.15%
Purpose
Oral antiseptic, Oral pain reliever, Oral astringent
Medication Information
Purpose
Oral antiseptic, Oral pain reliever, Oral astringent
Description
Belzalkonium chloride 0.13% Benzocaine 20% Menthol 0.5% Zinc chloride 0.15%
Use
- for the temporary relief of pain due to minor irritation or injury of the mouth and gums
- first aid to help prevent infection in minor oral irritation
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 the 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 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
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 Tamper-Evident tab is open before first use
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Active Ingredients
Belzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.5%
Zinc chloride 0.15%
Inactive Ingredients
ammonium glycyrrhizate, blue 1, 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 RELIEVER BRAND FOR TOOTHACHE
Ready-Open Tube Tip
Orajel
4X MEDICATED FOR TOOTHACHE AND GUM GEL
INSTANT PAIN RELIEF
Clinical Strength for Pain Relief
Proven to Kill Harmful Bacteria
Helps Prevent Infection
Cooling Relief for Gum Irritation
ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT
NET WT
0.25 oz (7.0 g)
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
Keep Out of Reach of Children
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
Structured Label Content
Use
- for the temporary relief of pain due to minor irritation or injury of the mouth and gums
- first aid to help prevent infection in minor oral irritation
Purpose
Oral antiseptic, 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 the 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 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
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 Tamper-Evident tab is open before first use
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Active Ingredients
Belzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.5%
Zinc chloride 0.15%
Inactive Ingredients
ammonium glycyrrhizate, blue 1, 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
Principal Display Panel
#1 ORAL PAIN RELIEVER BRAND FOR TOOTHACHE
Ready-Open Tube Tip
Orajel
4X MEDICATED FOR TOOTHACHE AND GUM GEL
INSTANT PAIN RELIEF
Clinical Strength for Pain Relief
Proven to Kill Harmful Bacteria
Helps Prevent Infection
Cooling Relief for Gum Irritation
ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT
NET WT
0.25 oz (7.0 g)
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
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
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:54.121948 · Updated: 2026-03-14T23:11:53.041179