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Rite Aid Maximum Strength by Rite Aid

Dosage form: gel, dentifrice
Ingredients: BENZOCAINE 20.0g in 100g, BENZALKONIUM CHLORIDE 0.04g in 100g, ZINC CHLORIDE 0.1g in 100g
Labeler: Rite Aid
NDC Code: 11822-0317

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.

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

  • 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

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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RITE AID  MAXIMUM STRENGTH
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0317
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20.0 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.04 g  in 100 g
ZINC CHLORIDE (ZINC CATION) ZINC0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYETHYLENE GLYCOLS 
SACCHARIN SODIUM 
SORBIC ACID 
POLYSORBATE 60 
POVIDONE K90 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
STEARYL ALCOHOL 
EDETATE DISODIUM 
ALLANTOIN 
PROPYLENE GLYCOL 
PROPYL GALLATE 
PEPPERMINT OIL 
Product Characteristics
Colorwhite (White / Clear to slight pinkish orange) Score    
ShapeSize
FlavorPEPPERMINT (Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-0317-91 TUBE (TUBE) 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/FEIOperations
Lornamead126440440manufacture(11822-0317), pack(11822-0317)

Revised: 01/2013
 
Rite Aid

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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