OTC Medication Information: 4X Medicated Toothache and Gum Gel
4X MEDICATED TOOTHACHE AND GUM GEL- benzocaine, zinc chloride, benzalkonium chloride and menthol gel
Walmart
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.
Benzalkonium chloride 0.13% … Oral antiseptic
Benzocaine 20% …. Oral pain reliever
Menthol 0.5% …. 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
Methemoglobinemia warning: use of this product may cause methoglobinemia, 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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount 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 teh use of this product * children under 2 years of age: do not use
Other information * do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient untill 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, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
Toothache & Gum
Relief Gel
*20’% Benzocaine to relieve oral pain
*Kills harmful bacteria
*Astringent to help prevent infection
*Cools gumm and relieves irritation
Fast Acting Gel
Compare to Orajel 4x Medicated for Toothache and Gum Gel Active Ingredients
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| Labeler — Walmart (051957769) |
| Registrant — Lornamead (080046418) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Lornamead | 080046418 | manufacture (49035-569) | |
Revised: 01/2023 Walmart
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/4x-medicated-toothache-and-gum-gel-2/