Label: PM TOOTHACHE RELIEF- benzocaine paste
- NDC Code(s): 0363-1623-09
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 22, 2024
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
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PURPOSE
Do not nuse if tube tip is cust 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.
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WARNINGS
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition tha tmust be treated promptly becuase 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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PM TOOTHACHE RELIEF
benzocaine pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1623 Route of Administration DENTAL 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 BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) CHAMOMILE (UNII: FGL3685T2X) SORBIC ACID (UNII: X045WJ989B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color white (cloudy white to yellow) Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1623-09 1 in 1 BOX 10/28/2022 1 7.1 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 Drug M017 10/27/2022 Labeler - Walgreens (008965063) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(0363-1623) , pack(0363-1623)