4X MEDICATED TOOTHACHE AND GUM GEL- benzocaine gel, dentifrice

4x Medicated Toothache and Gum Gel by

Drug Labeling and Warnings

4x Medicated Toothache and Gum Gel by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets INC, Lornamead Inc, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.5%

Zinc Chloride 0.15%

PURPOSE

Oral antiseptic

Oral pain reliever

Oral astringent

INDICATIONS & USAGE

temporary relief of pain due to toothache * to help protect against infection of minor oral irritation

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:

pale, gray, or blue colored skin (cyanosis)

headache

rapid heart rate

shortness of breath

dizziness or lightheadness

fatique or lack of energy

Alergy 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

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

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

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

DOSAGE & ADMINISTRATION

Directions

cut open tip of tube on score mark

adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.

children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product

children under 2 years of age: do not use

do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted *do not use continuously *this formula will stay in place for extended duration of relief *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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

PUBLIX SUPER MARKETS, 3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL

PUBLIX SUPER MARKETS, INC

4X MEDICATED GEL

TOOTHACHE & GUM PAIN RELIEF

• 20% Benzocaine to relieve oral pain
• Kills harmful bacteria
• Astringent to help prevent infection
• Cools gum & relieves irritation

Compare to the active ingredients in Orajel

4X medicated for toothache & Gum gel*

NET WT 0.25OZ (7 g)

INGREDIENTS AND APPEARANCE

4X MEDICATED TOOTHACHE AND GUM GEL 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-312
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SORBIC ACID (UNII: X045WJ989B)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)

Product Characteristics
Color	blue (blue to Blue Green)	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-312-22	1 in 1 CARTON	09/01/2024
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 Drug	M022	09/01/2024

Labeler - Publix Super Markets INC (006922009)

Registrant - Lornamead Inc (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	pack(56062-312) , manufacture(56062-312)