4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzalkonium chloride gel
Meijer
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
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 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 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
• 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
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 children under 12 years of age should be supervised in the use of this product • children under a dentist or doctor • 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 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
NDC 41250- 061-19
*Compare to the active ingredient in Orajel™ 4X Medicated For Toothache & Gum Gel
4X MEDICATED
toothache & gum
pain relief gel
Immediate Pain Relief
20% Benzocaine to Relieve Oral Pain
Antiseptic to Kill Harmful Batceria
Astringent to Help Prevent Infection
Menthol to cool Gum & Relieves Irritation
4X MEDICATED SEVERE TOOTHACHE AND GUM GEL
benzalkonium chloride gel |
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Labeler - Meijer (006959555) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Lornamead | 080046418 | manufacture(79481-0610) , pack(79481-0610) |