5820617 Rite Aid 3x Medicated Mouth Sore Gel (80-15600)

5820617 Rite Aid 3x Medicated Mouth Sore Gel (80-15600)
SPL v7
SPL
SPL Set ID 997064c9-24bb-7fb1-e053-2995a90ace7c
Route
ORAL
Published
Effective Date 2020-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Menthol (0.1 g) Zinc Cation (0.15 g)
Inactive Ingredients
Propylene Glycol Water Saccharin Polysorbate 60 Methyl Salicylate Stearyl Alcohol Allantoin Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Povidone K90 Sorbic Acid Polyethylene Glycol 400 Edetic Acid

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-05 Until 2027-01-01

Description

Benzocaine 20% . . . Oral Pain Reliever Menthol 0.1% . . . 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 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 procain, butacaine, benzocaine or other "caine" anesthetics

Do not use * more than directied * 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

Benzocaine 20% . . . Oral Pain Reliever Menthol 0.1% . . . Oral Pain Reliever Zinc chloride 0.15% . . . Oral Astringent

Uses

temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

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

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

Section 51945-4

Section 55106-9

Benzocaine 20% . . . Oral Pain Reliever

Menthol 0.1% . . . Oral Pain Reliever

Zinc chloride 0.15% . . . Oral Astringent

Directions

cut open tip of tube on score mark * adults and children 2 years of age and older: apply to affected area 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


Structured Label Content

Uses

temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

Warnings and Precautions (34071-1)

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because 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 procain, butacaine, benzocaine or other "caine" anesthetics

Do not use * more than directied * 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)

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Benzocaine 20% . . . Oral Pain Reliever

Menthol 0.1% . . . Oral Pain Reliever

Zinc chloride 0.15% . . . Oral Astringent

Directions

cut open tip of tube on score mark * adults and children 2 years of age and older: apply to affected area 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


Advanced Ingredient Data


Raw Label Data

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