The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product 4x Medicated Severe Toothache And Gum Cream (NDC 11822-0614). 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 otc - active ingredient, use, indications & usage, allergy alert, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient Purpose
Belkonium 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 toothaches * to help protect against infection of minor oral irritation
Warnings
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces teh 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
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 * symtoms do not improve in 7 days * allergic reaction occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions * cut open tip of tube on score mark * dults and children 2 years of age and older; apply a small amount of product to the 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 the use of this product * children under 2 years of age: do not use
Other information * do not use if the tip is cut 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
Inactive ingredients ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide
Toothache & gum reliever
20% benzocaine to relieve oral pain
antiseptic to kill harmful bacteria
astringent to help prevent infection
menthol to soothe gums
4x medicated
oral antiseptic/pain reliever/astringent
Net Wt 0.33 oz (9.4 g)
* Please review the disclaimer below.
