Label: REXALL MAXIMUM STRENGTH- benzocaine liquid
- NDC Code(s): 55910-346-79
- Packager: Rexall
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 7, 2024
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- Active ingredient
- Uses
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WARNINGS
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
When using this product
- avoid contact with eyes
- do not exceed recommended dosage
- Do not use more than directed for more than 7 days unless directed by a dentist or doctor.
Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens swelling rash or fever developes
- Directions
- Other Information
- Inactive ingredients
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REXALL MAXIMUM STRENGTH
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-346 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 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLPARABEN (UNII: A2I8C7HI9T) BENZYL ALCOHOL (UNII: LKG8494WBH) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color orange (dark orange/red to sl brown) Score Shape Size Flavor MINT (Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-346-79 1 in 1 CARTON 02/01/2023 1 14.7 mL in 1 BOTTLE; 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 01/01/2015 Labeler - Rexall (068331990) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations HK KOLMAR CANADA, INC 243501959 manufacture(55910-346) , pack(55910-346)