Theracare Maximum Strength Oral Pain Relief
d8270f1c-b44e-ae00-e053-2a95a90aa409
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Benzocaine 20% Benzalkonium Chloride 0.1%
Purpose
Oral pain reliever Antiseptic
Medication Information
Purpose
Oral pain reliever
Antiseptic
Dosage and Administration
Directions
- Adults and children 2 years of age and over - Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
- Children under 12 years of age - Should be supervised in the use of this product
- Children under 2 years of age - Ask a physician or healthcare provider
Description
Benzocaine 20% Benzalkonium Chloride 0.1%
Use
- for the temporary relief of pain due to toothaches
- to help protect against infection in minor oral irritation
Section 50565-1
KEEP OUT OF REACH OF CHILDREN:
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Section 50569-3
Stop use and ask a physician if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
Section 50570-1
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
Section 51945-4
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
Other Information
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
- do not use if tube seal under cap is broken
- store at 20-25C (68-77F)
Active Ingredients
Benzocaine 20%
Benzalkonium Chloride 0.1%
Inactive Ingredients
Glycerin, polyethylene glycol, saccharin sodium, sodium polyacrylate, sorbic acid, sorbitol, strawberry furanone, water.
Questions Or Comments?
TOLL FREE 866-326-1313 M-F 8:30 am-4:30 pm CST
Structured Label Content
Use
- for the temporary relief of pain due to toothaches
- to help protect against infection in minor oral irritation
Dosage and Administration (34068-7)
Directions
- Adults and children 2 years of age and over - Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
- Children under 12 years of age - Should be supervised in the use of this product
- Children under 2 years of age - Ask a physician or healthcare provider
Section 50565-1 (50565-1)
KEEP OUT OF REACH OF CHILDREN:
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Section 50569-3 (50569-3)
Stop use and ask a physician if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
Section 50570-1 (50570-1)
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
Section 51945-4 (51945-4)
Purpose
Oral pain reliever
Antiseptic
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
Other Information (Other information)
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
- do not use if tube seal under cap is broken
- store at 20-25C (68-77F)
Active Ingredients (Active ingredients)
Benzocaine 20%
Benzalkonium Chloride 0.1%
Inactive Ingredients (Inactive ingredients)
Glycerin, polyethylene glycol, saccharin sodium, sodium polyacrylate, sorbic acid, sorbitol, strawberry furanone, water.
Questions Or Comments? (Questions or comments?)
TOLL FREE 866-326-1313 M-F 8:30 am-4:30 pm CST
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:55.139425 · Updated: 2026-03-14T23:06:04.571747