5820606 Dg 4x Medicated Toothache & Gum Cream

5820606 Dg 4x Medicated Toothache & Gum Cream
SPL v6
SPL
SPL Set ID b2c156f0-6d11-1eba-e053-2995a90a6db8
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (0.15 g) Benzalkonium (0.13 g) Menthol, Unspecified Form (0.26 g) Benzocaine (20 g)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Glycyrrhizin Saccharin Sorbic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-28

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 product before. Stop use and seek immediate medical attention if you or a child in your care develop

  • 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

  • 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

Stop use and ask a doctor if

  • symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens

Keep out reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion Control Center right away.

Indications and Usage

Uses

  • for the temporary relief of pain due to minor irritation or njury of the mouth and gums
  • first aid to help prevent inceftion in mior oral irritation
Dosage and Administration

cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to teh cavity and around teh gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in teh use of this product * children under 2 years of age: do not use

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, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Section 51945-4

Section 55105-1

Oral antiseptic

Oral pain reliever

Oral pain reliever

Oral astringent

Section 55106-9

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Section 60561-8

Other information

  • do not use if tip is cut prior to opening
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of pain due to minor irritation or njury of the mouth and gums
  • first aid to help prevent inceftion in mior 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 a small amount of product to teh cavity and around teh gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in teh use of this product * children under 2 years of age: do not use

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 product before. Stop use and seek immediate medical attention if you or a child in your care develop

  • 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

  • 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

Stop use and ask a doctor if

  • symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens

Keep out reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion Control Center right away.

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 51727-6 (51727-6)

ammonium glycyrrhizate, flavor, 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 pain reliever

Oral astringent

Section 55106-9 (55106-9)

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Section 60561-8 (60561-8)

Other information

  • do not use if tip is cut prior to opening
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)