Dosage & Administration
For the temporary relief of pain due to toothaches. To help protect aganist infection of minor oral irritation.
Pm Toothache Relief Cream
FDA Label NDC 69842-623
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Pm Toothache Relief (NDC 69842-623). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, inactive ingredient, indications & usage, otc - active ingredient, otc - keep out of reach of children, otc - purpose, warnings, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-77, sodium saccharin, sorbic acid, titanium dioxide
Indications & 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.
Otc - Active Ingredient
Belzalkomium Chloride 0.13% Oral antiseptic
Benzocaine 20% Oral pain releiver
Methol 0.26% Oral pain releiver
Zinc chloride 0.15% Oral astringent
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a POison Control Center right away.
Otc - Purpose
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.
Warnings
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.
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)
Carton R1 (Cvs 4xmedpm Cream Ctn 2821625r1 Ol)
* Please review the disclaimer below.
