5820608 4x Med Gel

5820608 4x Med Gel
SPL v6
SPL
SPL Set ID a71c47de-d35d-49da-e053-2995a90a823c
Route
ORAL
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (0.5 g) Zinc Cation (0.15 g) Benzalkonium (0.13 g) Benzocaine (20 g)
Inactive Ingredients
Polyethylene Glycol 3350 Polyethylene Glycol 400 Sorbic Acid Saccharin Methyl Salicylate Fd&c Blue No. 1 Glycyrrhizin

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-02

Description

Active ingredients Purpose Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever Menthol 0.5% . . . . . . . . . . . . . . . .Oral pain reliever Zinc chloride 0.15% . . . . . . . . . . .Oral astringent


Medication Information

Warnings and Precautions

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because ti reduces the amount of oxygen in teh 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

Description

Active ingredients Purpose 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

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 50566-9

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

Section 51727-6

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

Section 51945-4

Section 55106-9

Active ingredients Purpose

Benzalkonium chloride 0.13% . . . Oral antiseptic

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

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

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

Section 60561-8

do not use if tip is cut rpior 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

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


Structured Label Content

Use

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

Warnings and Precautions (34071-1)

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because ti reduces the amount of oxygen in teh 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

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 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active ingredients Purpose

Benzalkonium chloride 0.13% . . . Oral antiseptic

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

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

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

Section 60561-8 (60561-8)

do not use if tip is cut rpior 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

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


Advanced Ingredient Data


Raw Label Data

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