5820345 Rite Aid Max Str Oral Pain Relief

5820345 Rite Aid Max Str Oral Pain Relief
SPL v15
SPL
SPL Set ID 340ccdab-0a02-454c-8d44-ced5667276ab
Route
ORAL
Published
Effective Date 2019-02-19
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 Methylparaben Benzyl Alcohol Fd&c Red No. 40 D&c Yellow No. 10 Fd&c Blue No. 1 Water

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-01 Until 2027-01-01
Description

Active ingredient Benzocaine 20% (w/w)

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 yoru care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lighteadedness
  • 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 the following mouth irritations

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
Dosage and Administration

Directions

Adults and children 2 years of age and older:

  • apply to affected area using applicator tip
  • 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

Active ingredient Benzocaine 20% (w/w)

Section 42229-5

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN CANADA

Section 44425-7

Other information

  • do not use if package has been opened
  • store at 20-25°C (68-77°F)
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 directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Section 51727-6

Inactive ingredients Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Section 51945-4

Section 55105-1

Purpose

Oral anesthetic

Section 55106-9

Active ingredient

Benzocaine 20% (w/w)

Structured Label Content

Indications and Usage (34067-9)

Use

temporarily relieves pain associated with the following mouth irritations

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:

  • apply to affected area using applicator tip
  • 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 yoru care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lighteadedness
  • 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)

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN CANADA

Section 44425-7 (44425-7)

Other information

  • do not use if package has been opened
  • store at 20-25°C (68-77°F)
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 directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Section 51727-6 (51727-6)

Inactive ingredients Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20% (w/w)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:12.519855 · Updated: 2026-03-14T23:10:26.709421