5820342 Topcare Max Str Oral Pain Relief Gel

5820342 Topcare Max Str Oral Pain Relief Gel
SPL v14
SPL
SPL Set ID 835fb6ac-dbb7-5566-e053-2991aa0af5e2
Route
TOPICAL
Published
Effective Date 2019-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Polyethylene Glycol, Unspecified Saccharin Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-05

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

  • for the temporary relief of pain due to toothaches
Dosage and Administration

Directions

  • cut open tip of tube on scoremark
  • adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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 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, 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 flavor, polyethylene glycol, sodium saccharin, sorbic acid

Section 51945-4

Section 55105-1

Purpose

Oral Pain Reliever

Section 55106-9

Active ingredient

Benzocaine 20%

Section 60561-8

Other information

  • do not use if tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a tempory expedient until a dentist can be consulted
  • do not use continuously

Structured Label Content

Indications and Usage (34067-9)

Use

  • for the temporary relief of pain due to toothaches
Dosage and Administration (34068-7)

Directions

  • cut open tip of tube on scoremark
  • adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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 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, 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 flavor, polyethylene glycol, sodium saccharin, sorbic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral Pain Reliever

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20%

Section 60561-8 (60561-8)

Other information

  • do not use if tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a tempory expedient until a dentist can be consulted
  • do not use continuously

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)