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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Rite Aid Max Str Oral Pain Relief Gel

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Use

temporarily relieves pain associated with mouth and gum irritations

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention of you or a child in your care develops:

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
  • for teething
  • in children under 2 years of age

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
  • allergic reaction occurs

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

Directions

Other information

store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

RITE AID® PHARMACY

MAXIMUM STRENGTH

oral pain relief

benzocaine 20%

anesthetic gel

instant pain relief for:

toothaches

gum pain

canker sores

denture pain

NET WT 0.33 OZ (9 g)

RA ORAL ANALGESIC GEL 2824366R2

RITE AID   MAXIMUM STRENGTH
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0316
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Characteristic Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0316-91 in 1 CARTON01/20/201103/04/2019
1NDC:11822-0316-214 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11822-0316-31 in 1 BLISTER PACK03/03/2019
29 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/20/2011
Labeler - Rite Aid (014578892)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(11822-0316)

Revised: 1/2023
Document Id: f1ffdcb0-fc2c-96bc-e053-2a95a90a5f49
Set id: 5e216587-5384-464a-a4dd-07943668cabd
Version: 20
Effective Time: 20230111
 
Rite Aid