4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzocaine 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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Active Ingredients Purpose

Benzalkonium Chloride 0.13% .... Oral Antiseptic

Benzocaine 20% ......................... Oral Pain Reliever

Menthol 0.5% .............................. Oral Pain Reliever

Zinc Chloride 0.15% .................... Oral Astringent

Use

Use * for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Warnings

Methemoglobinemia warning: use of this product ay cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in teh 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: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightneadedness * fatigue or lack of energy

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

* cut open tip of tube to score mark * adults and children 2 years of age and older: apply a small amount of product to teh cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

Other Information

Other information * do not use if tip is cut prior to ening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use ontinuously * this formula will stay in place for extended duration of reilef * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

Full artworkToothache & Gum Reliever

20% Benzocaine to relieve oral pain

Antiseptic to kill harmful bacteria

Astringent to help prevent infection

Menthol to soothe gums

4x medicated

Oral antiseptic/pain reliever/astringent

Net Wt 0.25 oz (7g)

4X MEDICATED SEVERE TOOTHACHE AND GUM GEL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0615
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
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
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBIC ACID (UNII: X045WJ989B)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0615-91 in 1 CARTON05/06/2020
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 finalpart35605/06/2020
Labeler - Rite Aid (014578892)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(11822-0615)

Revised: 1/2023
Document Id: f2000136-02ee-19d3-e053-2995a90ab647
Set id: 99703bf4-f169-5e05-e053-2995a90afab4
Version: 10
Effective Time: 20230111
 
Rite Aid