4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzocaine gel

4X Medicated Severe Toothache and Gum Gel by

Drug Labeling and Warnings

4X Medicated Severe Toothache and Gum Gel by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Toothache & 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)

INGREDIENTS AND APPEARANCE

4X MEDICATED SEVERE TOOTHACHE AND GUM GEL 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0615
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.15 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0615-9	1 in 1 CARTON	05/06/2020
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/06/2020

Labeler - Rite Aid (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(11822-0615)