DG 3X MEDICATED TOOTHACHE ADN GUM GEL- benzocaine gel

DG 3x Medicated Toothache adn Gum Gel by

Drug Labeling and Warnings

DG 3x Medicated Toothache adn Gum Gel by is a Otc medication manufactured, distributed, or labeled by Dollar General, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

PURPOSE

Oral pain reliever

Oral pain reliever

Oral astringent

INDICATIONS & USAGE

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

WARNINGS

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

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DG 3X MEDICATED TOOTHACHE ADN GUM GEL 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-816
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
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.15 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.26 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)

Product Characteristics
Color	white (Cloudy White to Yellow)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-816-69	1 in 1 CARTON	10/28/2020
1		9.4 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	10/28/2020

Labeler - Dollar General (068331990)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(55910-816) , pack(55910-816)