REXALL MAXIMUM STRENGTH- benzocaine liquid

Rexall by

Drug Labeling and Warnings

Rexall by is a Otc medication manufactured, distributed, or labeled by Rexall, Lornamead, CSR Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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:

• 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.

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

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

REXALL  MAXIMUM STRENGTH
benzocaine liquid

Product 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: 55910-346-69	1 in 1 CARTON	01/13/2015
1	NDC: 55910-346-61	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 not final	part356	01/01/2015

Labeler - Rexall (068331990)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions		243501959	manufacture(55910-346) , pack(55910-346)