5820366 Rite Aid Max Str Oral Pain Relief Gel

5820366 Rite Aid Max Str Oral Pain Relief Gel
SPL v26
SPL
SPL Set ID 5e216587-5384-464a-a4dd-07943668cabd
Route
ORAL
Published
Effective Date 2019-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Saccharin Sodium Sorbic Acid Glycerin Fd&c Red No. 40 D&c Yellow No. 10 Fd&c Blue No. 1 Water Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-01-20 Until 2026-11-30

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 of 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 mouth and gum irritations

Dosage and Administration

Directions

  • to open tube, cut tip of tube on score mark
  • adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist/doctor
  • 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 a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

store at 20-25°C (68-77°F). Do not refrigerate.

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 Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10

Section 51945-4

Section 55105-1

Purpose

Oral anesthetic

Section 55106-9

Active ingredient

Benzocaine 20%


Structured Label Content

Indications and Usage (34067-9)

Use

temporarily relieves pain associated with mouth and gum irritations

Dosage and Administration (34068-7)

Directions

  • to open tube, cut tip of tube on score mark
  • adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist/doctor
  • 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 a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
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 of 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

store at 20-25°C (68-77°F). Do not refrigerate.

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 Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)