5820621 Albertsons 4x Cream

5820621 Albertsons 4x Cream
SPL v7
SPL
SPL Set ID b81a308c-9c30-0e3d-e053-2a95a90a15d2
Route
ORAL
Published
Effective Date 2025-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-07

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 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

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

Indications and Usage
  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums
  • first aid to help prevent infection in 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
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 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
  • 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)
  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums
  • first aid to help prevent infection in 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
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

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 50565-1 (50565-1)

Keep out of reach of children. In case of overdose or allergic reaction, 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)
  • 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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