Orajel 3x Medicated For All Mouth Sores, Gel
99b589ac-9833-fb60-e053-2995a90a0935
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Benzocaine 20% Menthol 0.1% Zinc Chloride 0.15%
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 0.1% Zinc Chloride 0.15%
Use
for the temporary relief of pain associated with canker sores, cold sores, fever blisters, 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
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water
Section 51945-4
#1 ORAL PAIN
RELIEF BRAND
FOR ADULTS
EXTRA STRENGTH
Orajel™
3X MOUTH SORES
MEDICATED
IMMEDIATE PAIN RELIEF
ORAL PAIN
RELIEVER/
ASTRINGENT
Provides
Long-Lasting
Pain Relief*
Helps Protect Sores
from Irritation
Delivers Targeted
Pain Relief
GEL
NET WT
0.18 OZ (5.1 g)
Section 55105-1
Oral pain reliever and Oral astringent
Section 55106-9
Benzocaine 20%
Menthol 0.1%
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
- sore mouth 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 associated with canker sores, cold sores, fever blisters, 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)
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water
Section 51945-4 (51945-4)
#1 ORAL PAIN
RELIEF BRAND
FOR ADULTS
EXTRA STRENGTH
Orajel™
3X MOUTH SORES
MEDICATED
IMMEDIATE PAIN RELIEF
ORAL PAIN
RELIEVER/
ASTRINGENT
Provides
Long-Lasting
Pain Relief*
Helps Protect Sores
from Irritation
Delivers Targeted
Pain Relief
GEL
NET WT
0.18 OZ (5.1 g)
Section 55105-1 (55105-1)
Oral pain reliever and Oral astringent
Section 55106-9 (55106-9)
Benzocaine 20%
Menthol 0.1%
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)
- sore mouth symptoms do not improve in 7 days
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:54.126536 · Updated: 2026-03-14T23:11:53.041179