5820632 Rite Aid Nighttime Toothache & Gum (8015632)

5820632 Rite Aid Nighttime Toothache & Gum (8015632)
SPL v3
SPL
SPL Set ID 21645ed1-2dc0-223a-e063-6394a90ab021
Route
ORAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g) Benzocaine (20 g) Zinc Cation (0.15 g) Menthol (0.26 g)
Inactive Ingredients
Titanium Dioxide Polyethylene Glycol 400 Chamomile Sorbic Acid Saccharin Sodium Ammonium Glycyrrhizate Polyethylene Glycol 3350

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Benzalkonium chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%


Medication Information

Warnings and Precautions

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 produt 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
  • for temporary relief of pain due to toothaches
  • to help protect against infection of minor oral irritation
Dosage and Administration

cut open 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 a dentist or doctor

children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product.

children under 2 years of age: do not use

Do not use:

  • more than directed
  • for more than 7 days unless told do so by a dentist or doctor
  • for teething
  • in children under 2 years of age
Description

Benzalkonium chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Section 50565-1

keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Section 51727-6

ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

Section 51945-4

Section 55105-1

oral antiseptic

oral pain reliever

oral astringent

Section 55106-9

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%


Structured Label Content

Indications and Usage (34067-9)
  • for temporary relief of pain due to toothaches
  • to help protect against infection of minor oral irritation
Dosage and Administration (34068-7)

cut open 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 a dentist or doctor

children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product.

children under 2 years of age: do not use

Do not use:

  • more than directed
  • for more than 7 days unless told do so by a dentist or doctor
  • for teething
  • in children under 2 years of age
Warnings and Precautions (34071-1)

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 produt 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 50565-1 (50565-1)

keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Section 51727-6 (51727-6)

ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

oral antiseptic

oral pain reliever

oral astringent

Section 55106-9 (55106-9)

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%


Advanced Ingredient Data


Raw Label Data

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