5820618 Dg 3x Med Gel

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (20 g) Zinc Cation (0.15 g) Menthol, Unspecified Form (0.26 g)

Inactive Ingredients

Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sorbic Acid Glycyrrhizin

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-10-28

Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and 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

Description

Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 55105-1

Oral pain reliever

Oral astringent

Section 55106-9

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral pain reliever

Oral astringent

Section 55106-9 (55106-9)

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN", "unii": "FST467XS7D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SORBIC ACID", "unii": "X045WJ989B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCYRRHIZIN", "unii": "6FO62043WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.26", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums", "34068-7": "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", "34071-1": "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", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away", "51727-6": "ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid", "55105-1": "Oral pain reliever Oral pain reliever Oral astringent", "55106-9": "Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%", "60561-8": "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"}