RITE AID MAXIMUM STRENGTH- benzocaine gel, dentifrice 
Rite Aid

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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

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

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

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Carton label

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Tube Label

RITE AID  MAXIMUM STRENGTH
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0317
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20.0 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.04 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White / Clear to slight pinkish orange) Score    
ShapeSize
FlavorPEPPERMINT (Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0317-91 in 1 CARTON
1NDC:11822-0317-211.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/20/2011
Labeler - Rite Aid (014578892)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(11822-0317) , pack(11822-0317)

Revised: 1/2013
Document Id: 4f5c75b0-7562-4dda-8418-418587c843a6
Set id: 9271a9d4-4e4d-486f-b426-c5b0053c7141
Version: 2
Effective Time: 20130109
 
Rite Aid