Label: 3X MEDICATED TOOTHACHE AND GUM GEL- benzocaine gel
- NDC Code(s): 11822-0613-9
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 12, 2023
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- ACTIVE INGREDIENT
- Use
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INDICATIONS & USAGE
Methemoglobinemia warning: use of this product may cause methemoglobinema, a serious condition that must be treated promptly because it reduces the amount of oxygen in the blood. This can occur even if you have used this prouct 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
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
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Directions
Directions * cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults adn 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
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OTHER SAFETY INFORMATION
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
3X MEDICATED TOOTHACHE AND GUM GEL
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0613 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.26 g in 100 g ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBIC ACID (UNII: X045WJ989B) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) Product Characteristics Color white (Cloudy white to beige) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0613-9 1 in 1 CARTON 05/06/2020 1 11.7 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/06/2020 Labeler - Rite Aid (014578892) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(11822-0613)
Toothache and Gum Reliever