Maximum Strength Oral Pain Relief

Maximum Strength Oral Pain Relief
SPL v3
SPL
SPL Set ID d98c1b2f-fe75-4d52-b082-1abb7628c59e
Route
ORAL
Published
Effective Date 2023-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.2 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer, Unspecified Type D&c Red No. 33 Fd&c Blue No. 1 Fd&c Yellow No. 6 Glycerin Polyethylene Glycol, Unspecified Polysorbate 80 Propylene Glycol Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-08

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)