RITE AID SEVERE TOOTHACHE AND GUM RELIEF  TRIPLE MEDICATED- benzocaine, menthol, zinc chloride 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.

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Rite Aid Severe Toothache & Gum Relief Gel Triple Med

Drug Facts

Active ingredients

Benzocaine 20%

Menthol 0.5%

Zinc Chloride 0.15%

Purpose

Oral pain reliever

Oral pain reliever

Astringent

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 directed by a dentist or doctor
  • for teething
  • in children under 2 years of age

Stop use and ask a doctor if

  • swelling, reash 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 ingredientsblue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

RITE AID® PHARMACY

SEVERE

toothache & gum relief

immediate relief of intense pain

fast acting GEL

ORAL PAIN RELIEVER / ASTRINGENT

triple medicated

NET WT 0.25 OZ (7.0 g)

RA Severe Pain Gel Triple Med 2821387R1

RITE AID SEVERE TOOTHACHE AND GUM RELIEF   TRIPLE MEDICATED
benzocaine, menthol, zinc chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-6038-91 in 1 CARTON03/04/2019
17 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(11822-6038)

Revised: 1/2023
Document Id: f200babf-07da-d922-e053-2a95a90a2179
Set id: 834850f1-6f72-3303-e053-2a91aa0adc7c
Version: 10
Effective Time: 20230111
 
Rite Aid