Theracare Maximum Strength Oral Pain Relief

Theracare Maximum Strength Oral Pain Relief
SPL v3
SPL
SPL Set ID d8270f1c-b44e-ae00-e053-2a95a90aa409
Route
TOPICAL
Published
Effective Date 2022-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg) Benzalkonium (10 mg)
Inactive Ingredients
Water Dimethylhydroxy Furanone Sodium Polyacrylate (8000 Mw) Saccharin Sodium Sorbic Acid Sorbitol Glycerin Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01

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

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