RITE AID  MAXIMUM TOOTHACHE RELIEVER- benzocaine, menthol gel 
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.

----------

Rite Aid Maximum Toothache Relief Double Med Gel

Drug Facts

Active ingredient

Benzocaine 20%

Menthol 0.26%

Purpose

Oral Pain Reliever

Oral Pain Reliever

Use

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 if 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

Inactive ingredientsAmmonium Glycyrrhizate, Flavor, Polyethylene Glycol, Sodium Saccharin, Sorbic Acid

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

TAMPER EVIDENT: Do not use if tube tip is cut prior to use

RITE AID® PHARMACY

MAXIMUM toothache reliever

immediate relief of toothache pain

Fast acting GEL

ORAL PAIN RELIEVER

Double Medicated

NET WT 0.42 OZ (12 g)

RA MaxStr Toothache Rel Gel 2821385R1

RITE AID   MAXIMUM TOOTHACHE RELIEVER
benzocaine, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.26 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-6036-91 in 1 CARTON03/04/2019
112 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 finalpart35603/04/2019
Labeler - Rite Aid (014578892)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(11822-6036)

Revised: 1/2023
Document Id: f200c412-ae63-40a3-e053-2995a90a4e41
Set id: 8347cb51-4d51-0b83-e053-2991aa0ad9e2
Version: 10
Effective Time: 20230111
 
Rite Aid