Rite Aid Tooth & Gum Pain Relief Cushions

Rite Aid Tooth & Gum Pain Relief Cushions
SPL v10
SPL
SPL Set ID 83467773-f9ba-2485-e053-2991aa0a5f8f
Route
TOPICAL
Published
Effective Date 2019-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (10 g)
Inactive Ingredients
Polyethylene Glycol, Unspecified Carboxymethylcellulose Sodium, Unspecified Form Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-04

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

  • Carefully remove gel cushion from blister. Gently mold iwth fingers until soft. Apply to affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth.
  • Adults and children 12 years of age and older: use up to 3 times daily or as directed by dentist or doctor.
  • Children under 12 years of age: ask a dentist or doctor
  • Children under 2 years of age: do not use
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

Do not use if blister card is broken. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously. These toothache cushions are designed to completely dissolve in place.

Store at room temperature 15-30°C (59-86°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 told to do so by a dentist or doctor
  • for teething
  • in children under 2 years of age
Section 51727-6

Inactive ingredients

Cellulose Gum, Flavor, Menthol, Polyethylene Glycol

Section 51945-4

RITE AID® PHARMACY

MEDICATED

tooth & gum pain relief cushions

benzocaine 10% • oral pain reliever

immediate pain relief

soothes & comforts

8 GEL CUSHIONS, 0.5 g EACH

Section 55105-1

Purpose

Oral Pain Reliever

Section 55106-9

Active ingredient

Benzocaine 10%


Structured Label Content

Indications and Usage (34067-9)

Use

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

Directions

  • Carefully remove gel cushion from blister. Gently mold iwth fingers until soft. Apply to affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth.
  • Adults and children 12 years of age and older: use up to 3 times daily or as directed by dentist or doctor.
  • Children under 12 years of age: ask a dentist or doctor
  • 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 44425-7 (44425-7)

Other information

Do not use if blister card is broken. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously. These toothache cushions are designed to completely dissolve in place.

Store at room temperature 15-30°C (59-86°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 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

Cellulose Gum, Flavor, Menthol, Polyethylene Glycol

Section 51945-4 (51945-4)

RITE AID® PHARMACY

MEDICATED

tooth & gum pain relief cushions

benzocaine 10% • oral pain reliever

immediate pain relief

soothes & comforts

8 GEL CUSHIONS, 0.5 g EACH

Section 55105-1 (55105-1)

Purpose

Oral Pain Reliever

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)