RITE AID MAXIMUM STRENGTH- benzocaine gel, dentifrice

Rite Aid by

Drug Labeling and Warnings

Rite Aid by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.02% .................................................... Oral Antiseptic

Benzocaine 7.5% ...................................................................... Oral Pain Reliever

Zinc Chloride 0.1% ................................................................... Oral Astringent

Uses

temporarily relieves pain caused by canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

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

• Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor.
• Stop use and ask a doctor if sore mouth symptoms do not get better in 7 days. swelling, rash or fever develops, irritation, pain or redness persists or worsens

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

Directions

cut open tip of tube on score mark. do not use if tip is cut prior to opening

Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a doctor. Children under 12 years should be supervised in the use of this product.

Childern under 2 years of age: ask a dentist or doctor

DOSAGE & ADMINISTRATION

Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a doctor. Children under 12 years should be supervised in the use of this product.

Childern under 2 years of age: ask a dentist or doctor

Other Information

Do not use if tip is cut prior to opening.

Inactive ingredients

Allantoin, Carbomer, Edetate Disodium, Mentha Piperota (Peppermint) Oil, Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

RITE AID  MAXIMUM STRENGTH
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0317
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20.0 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.04 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POVIDONE K90 (UNII: RDH86HJV5Z)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALLANTOIN (UNII: 344S277G0Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	white (White / Clear to slight pinkish orange)	Score
Shape		Size
Flavor	PEPPERMINT (Peppermint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0317-9	1 in 1 CARTON
1	NDC: 11822-0317-2	11.9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/20/2011

Labeler - Rite Aid (014578892)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	manufacture(11822-0317) , pack(11822-0317)