MedPath

DG 3x Medicated Toothache adn Gum Gel

5820618 DG 3x Med Gel

Approved
Approval ID

b2c0e442-4cba-589d-e053-2995a90a6bca

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Dollar General

DUNS: 068331990

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 Code55910-816
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 (8)

POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
BENZOCAINEActive
Quantity: 20 g in 100 g
Code: U3RSY48JW5
Classification: ACTIB
ZINC CHLORIDEActive
Quantity: 0.15 g in 100 g
Code: 86Q357L16B
Classification: ACTIM
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
MENTHOL, UNSPECIFIED FORMActive
Quantity: 0.26 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/28/2020

Tube Artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/28/2020

for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/28/2020

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/28/2020

Oral pain reliever

Oral pain reliever

Oral astringent

WARNINGS SECTION

LOINC: 34071-1Updated: 10/28/2020

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 uness 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 * allergeic 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: 10/28/2020

cut open tip of tube on 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 SAFETY INFORMATION

LOINC: 60561-8Updated: 10/28/2020

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 * retain carton for complete product information

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/28/2020

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

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