4x Medicated Severe Toothache and Gum Gel by is a Otc medication manufactured, distributed, or labeled by Lornamead. Drug facts, warnings, and ingredients follow.
4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzocaine gel
Lornamead
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Benzalkonium chloride 0.13% . . . Oral antiseptic
Benzocaine 20% . . . Oral pain reliever
Menthol 0.5% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
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 immeditate 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
Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to the cavity and around the 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 inforation * do not use if tip of tube 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
4X MEDICATED SEVERE TOOTHACHE AND GUM GEL
benzocaine gel |
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Labeler - Lornamead (126440440) |
Registrant - Lornamead (080046418) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Lornamead | 080046418 | manufacture(62721-5602) |