4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzalkonium chloride 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 Meijer, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium chloride 0.13% ..................................Oral antiseptic

Benzocaine 20% .....................................................Oral pain reliever

Menthol 0.5% ........................................................Oral pain reliever

Zinc chloride 0.15% ................................................Oral astringent

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 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 lightheadedness 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

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

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 children under 12 years of age should be supervised in the use of this product children under a dentist or doctor 2 years of age: do not use

Other Information

Other information 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 I

PRINCIPAL DISPLAY PANEL

NDC 41250- 061-19

*Compare to the active ingredient in Orajel™ 4X Medicated For Toothache & Gum Gel

4X MEDICATED

toothache & gum

pain relief gel

Immediate Pain Relief

20% Benzocaine to Relieve Oral Pain

Antiseptic to Kill Harmful Batceria

Astringent to Help Prevent Infection

Menthol to cool Gum & Relieves Irritation

INGREDIENTS AND APPEARANCE

4X MEDICATED SEVERE TOOTHACHE AND GUM GEL 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-0610
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
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 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)
SORBIC ACID (UNII: X045WJ989B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

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: 79481-0610-9	1 in 1 CARTON	11/20/2019
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	11/20/2019

Labeler - Meijer (006959555)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(79481-0610) , pack(79481-0610)