Maximum Strength Oral Pain Relief
d98c1b2f-fe75-4d52-b082-1abb7628c59e
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts Active ingredients Purpose Benzocaine 20%....................................................................Oral pain reliever
Medication Information
Warnings and Precautions
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.
Do not use:
- for teething
- in children under 2 years of age
Indications and Usage
Uses
- temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- canker sores
- minor dental procedures
- dentures
- sore gums
- braces
Dosage and Administration
Directions:
|
adults and children 2 years of age and over |
apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist |
|
children under 12 years of age |
adult supervision should be given in the use of this product |
|
children under 2 years of age |
do not use |
- For denture irritation:
- apply thin layer to the affected area
- do not reinsert dental work until irritation/pain is relieved
- rinse mouth well before reinserting
Other information
- store at 20-25°C (68-77°F)
- do not refrigerate
Description
Drug Facts Active ingredients Purpose Benzocaine 20%....................................................................Oral pain reliever
Section 50565-1
Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Section 50569-3
When using this product:
- avoid contact with the eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a doctor/dentist
Stop use and ask doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness lasts or worsens
- swelling, rash, or fever develops
Section 51727-6
Inactive Ingredients
benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid
Section 55106-9
Drug Facts
|
Active ingredients Purpose |
|
Benzocaine 20%....................................................................Oral pain reliever |
Package Label.principal Display Panel
MAXIMUM STRENGTH
ORAL PAIN RELIEF GEL
FAST ACTING
Benzocaine 20% pain relieving gel
NET WT 0.5 OZ (14g)
Structured Label Content
Indications and Usage (34067-9)
Uses
- temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- canker sores
- minor dental procedures
- dentures
- sore gums
- braces
Dosage and Administration (34068-7)
Directions:
|
adults and children 2 years of age and over |
apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist |
|
children under 12 years of age |
adult supervision should be given in the use of this product |
|
children under 2 years of age |
do not use |
- For denture irritation:
- apply thin layer to the affected area
- do not reinsert dental work until irritation/pain is relieved
- rinse mouth well before reinserting
Other information
- store at 20-25°C (68-77°F)
- do not refrigerate
Warnings and Precautions (34071-1)
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.
Do not use:
- for teething
- in children under 2 years of age
Section 50565-1 (50565-1)
Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Section 50569-3 (50569-3)
When using this product:
- avoid contact with the eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a doctor/dentist
Stop use and ask doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness lasts or worsens
- swelling, rash, or fever develops
Section 51727-6 (51727-6)
Inactive Ingredients
benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid
Section 55106-9 (55106-9)
Drug Facts
|
Active ingredients Purpose |
|
Benzocaine 20%....................................................................Oral pain reliever |
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
MAXIMUM STRENGTH
ORAL PAIN RELIEF GEL
FAST ACTING
Benzocaine 20% pain relieving gel
NET WT 0.5 OZ (14g)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:34.171179 · Updated: 2026-03-14T23:11:10.262850