REXALL MAXIMUM STRENGTH- benzocaine liquid 
Rexall

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5820346 DG Max Str OP Relief Liq

Active ingredient

Benzocaine 20.0% ..................................Purpose: Oral pain reliever

Uses

Temporarily relieves pain associated with the following mouth irritations  toothache sore gums canker sores braces minor dental procedures

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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older:

Children under 2 years of age: ask a dentist or doctor.

Other Information

Do not use if package has been opened

Store at 20-25°C (68-77°F)

Inactive ingredients

Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Methylparaben, Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
use 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: ask a dentist or doctor.

Card R3

REXALL  MAXIMUM STRENGTH
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-346
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Colororange (dark orange/red to sl brown) Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-346-791 in 1 CARTON02/01/2023
114.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/01/2015
Labeler - Rexall (068331990)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
HK KOLMAR CANADA, INC243501959manufacture(55910-346) , pack(55910-346)

Revised: 3/2024
Document Id: 13170abe-54cf-4cb3-e063-6394a90a150b
Set id: 8f6e2780-cfb7-4bef-9b7d-13cb80d8923e
Version: 9
Effective Time: 20240307
 
Rexall