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4x Medicated Toothache and Gum Gel

5820602 4x Med Gel

Approved
Approval ID

a7577d5f-69cf-3f32-e053-2995a90aaba5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

CVS

DUNS: 062312574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69842-642
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (11)

BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 g
Code: F5UM2KM3W7
Classification: ACTIB
BENZOCAINEActive
Quantity: 20 g in 100 g
Code: U3RSY48JW5
Classification: ACTIB
MENTHOL, UNSPECIFIED FORMActive
Quantity: 0.5 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
ZINC CHLORIDEActive
Quantity: 0.15 g in 100 g
Code: 86Q357L16B
Classification: ACTIM
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/5/2020

Carton Artwork

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/5/2020

Use

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/5/2020

Benzalkonium chloride 0.13% . . . Oral antiseptic

Benzocaine 20% . . . Oral pain reliever

Menthol 0.5% . . . Oral pain reliever

Zinc chloride 0.15% . . . Oral astringent

WARNINGS SECTION

LOINC: 34071-1Updated: 6/5/2020

Methemoglobinema warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly becuase 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

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 imporve 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/5/2020

Directions

cut open tip of tube on score mark * dults and children 2 years of age and older: apply a small amount of product to the cavity and around teh 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 SAFETY INFORMATION

LOINC: 60561-8Updated: 6/5/2020

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 least one hour after applying

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/5/2020

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

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4x Medicated Toothache and Gum Gel - FDA Drug Approval Details