Label: QUALITY CHOICE ORAL PAIN RELIEF- benzocaine 20%, benzalkonium chloride 1% gel
- NDC Code(s): 83324-035-12
- Packager: Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 15, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
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Warnings
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
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
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Adults and children 2 years of age and over - 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 a physician or healthcare provider
- 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 information
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
- do not use if tube seal under cap is broken
- store at 20-25C (68-77F)
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE ORAL PAIN RELIEF
benzocaine 20%, benzalkonium chloride 1% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83324-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83324-035-12 1 in 1 CARTON 04/01/2024 1 11.9 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 M022 04/01/2024 Labeler - Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) (011920774) Establishment Name Address ID/FEI Business Operations Astonea Labs Private Label 878533295 manufacture(83324-035)
