5820625 Cvs Health 4x Medicated Cream Pm

5820625 Cvs Health 4x Medicated Cream Pm
SPL v4
SPL
SPL Set ID 0a5a8cd0-d680-8a0f-e063-6294a90aa65c
Route
DENTAL
Published
Effective Date 2022-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-17

Description

For the temporary relief of pain due to toothaches. To help protect aganist infection of minor oral irritation.


Medication Information

Warnings and Precautions

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition tha tmust be treated promptly becuase 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.

Indications and Usage

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 should be supervised in the use of this product. Children under 2 years of age: do not use.

Dosage and Administration

For the temporary relief of pain due to toothaches. To help protect aganist infection of minor oral irritation.

Description

For the temporary relief of pain due to toothaches. To help protect aganist infection of minor 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 51727-6

ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-77, sodium saccharin, sorbic acid, titanium dioxide

Section 55105-1

Do not nuse if tube tip is cust prior to opening. 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 . This formula will stay in place for extended duration of relief. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

Section 55106-9

Belzalkomium Chloride 0.13% Oral antiseptic

Benzocaine 20% Oral pain releiver

Methol 0.26% Oral pain releiver

Zinc chloride 0.15% Oral astringent

Principal Display Panel

20% benzocaine to releive oral pain

Kills harmful bacteria

Astringent to help prevent infection

Cools gums and relieves irritation

Net Wt 0.25 oz (7g)


Structured Label Content

Indications and Usage (34067-9)

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 should be supervised in the use of this product. Children under 2 years of age: do not use.

Dosage and Administration (34068-7)

For the temporary relief of pain due to toothaches. To help protect aganist infection of minor oral irritation.

Warnings and Precautions (34071-1)

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition tha tmust be treated promptly becuase 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.

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, chamomile, flavor, mineral oil, PEG-8, PEG-77, sodium saccharin, sorbic acid, titanium dioxide

Section 55105-1 (55105-1)

Do not nuse if tube tip is cust prior to opening. 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 . This formula will stay in place for extended duration of relief. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

Section 55106-9 (55106-9)

Belzalkomium Chloride 0.13% Oral antiseptic

Benzocaine 20% Oral pain releiver

Methol 0.26% Oral pain releiver

Zinc chloride 0.15% Oral astringent

Principal Display Panel

20% benzocaine to releive oral pain

Kills harmful bacteria

Astringent to help prevent infection

Cools gums and relieves irritation

Net Wt 0.25 oz (7g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)