5820388 Family Wellness Max Str Oral Pain Relief
ddd0a678-3cee-42a1-a34e-a870e2dd4a4f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
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
Indications and Usage
Use
Temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- sore gums
- canker sores
- braces
- minor dental procedures
Dosage and Administration
Directions
Adults and children 2 years of age and older:
- apply to affected area using applicator tip
- use up to 4 times daily or as directed by a dentist or doctor
- children under 12 years of age should be supervised in the use of this product
children under 2 years of age: do not use
Description
Drug Facts
Section 42229-5
Drug Facts
Section 44425-7
Other information
- do not use if package has been opened
- store at 20 - 25 C (68-77F)
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
Section 50570-1
Do not use
- more than directed
- for more than 7 days unless told to do so by a dentist or doctor
- for teething
- in children under 2 years of age
Section 51727-6
Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water
Section 51945-4
FAMILY WELLNESS
MAXIMUM STRENGTH
Oral Pain Relief
20% Benzocaine
Liquid Anesthetic
0.5 FL OZ (14.7 mL)
Section 55105-1
Purpose
Oral anesthetic
Section 55106-9
Active ingredient
Benzocaine 20% (W/W)
Structured Label Content
Indications and Usage (34067-9)
Use
Temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- sore gums
- canker sores
- braces
- minor dental procedures
Dosage and Administration (34068-7)
Directions
Adults and children 2 years of age and older:
- apply to affected area using applicator tip
- use up to 4 times daily or as directed by a dentist or doctor
- children under 12 years of age should be supervised in the use of this product
children under 2 years of age: do not use
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
Section 42229-5 (42229-5)
Drug Facts
Section 44425-7 (44425-7)
Other information
- do not use if package has been opened
- store at 20 - 25 C (68-77F)
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
Section 50570-1 (50570-1)
Do not use
- more than directed
- for more than 7 days unless told to do so by a dentist or doctor
- for teething
- in children under 2 years of age
Section 51727-6 (51727-6)
Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water
Section 51945-4 (51945-4)
FAMILY WELLNESS
MAXIMUM STRENGTH
Oral Pain Relief
20% Benzocaine
Liquid Anesthetic
0.5 FL OZ (14.7 mL)
Section 55105-1 (55105-1)
Purpose
Oral anesthetic
Section 55106-9 (55106-9)
Active ingredient
Benzocaine 20% (W/W)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:00:53.597455 · Updated: 2026-03-14T23:01:12.726296