Label: 4X MEDICATED TOOTHACHE AND GUM GEL- benzocaine gel
- NDC Code(s): 49035-569-99
- Packager: Walmart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 23, 2023
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- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
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
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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INDICATIONS & USAGE
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
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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 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 INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
4X MEDICATED TOOTHACHE AND GUM GEL
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-569 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 ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.15 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength SORBIC ACID (UNII: X045WJ989B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYL SALICYLATE (UNII: LAV5U5022Y) Product Characteristics Color blue Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-569-99 1 g in 1 TUBE; Type 0: Not a Combination Product 05/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/18/2020 Labeler - Walmart (051957769) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(49035-569)
4x Medicated