5820611 4x Med Cream

5820611 4x Med Cream
SPL v5
SPL
SPL Set ID a71c5259-cbcf-7566-e053-2995a90a2cb6
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Benzalkonium (0.13 g) Zinc Cation (0.15 g) Menthol, Unspecified Form (0.25 g)
Inactive Ingredients
Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sorbic Acid Titanium Dioxide Glycyrrhizin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-02

Description

Active ingredients Purpose Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever Zinc chloride 0.15% . . . . . . . . . . .Oral astringent


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 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

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
Dosage and Administration

Directions

  • 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 under 12 years of age: ask doctor before use. Should be supervised in the use of this product
  • children under 2 years of age: do not use
Description

Active ingredients Purpose Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever Zinc chloride 0.15% . . . . . . . . . . .Oral astringent

Use

for the temporary relief of pain due to minor irritation of injury of the mouth and gums

  • first aid to help prevent infection in miro oral irritation
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

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

Active ingredients Purpose

Benzalkonium chloride 0.13% . . . Oral antiseptic

Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever

Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever

Zinc chloride 0.15% . . . . . . . . . . .Oral astringent

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

Use

for the temporary relief of pain due to minor irritation of injury of the mouth and gums

  • first aid to help prevent infection in miro oral irritation
Dosage and Administration (34068-7)

Directions

  • 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 under 12 years of age: ask doctor before use. Should be supervised in the 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 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

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 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

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

Active ingredients Purpose

Benzalkonium chloride 0.13% . . . Oral antiseptic

Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever

Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever

Zinc chloride 0.15% . . . . . . . . . . .Oral astringent

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

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