5820622 Walgreens Nbe Anbesol Gel

5820622 Walgreens Nbe Anbesol Gel
SPL v6
SPL
SPL Set ID dd2a3125-32f8-5fff-e053-2995a90ac720
Route
ORAL
Published
Effective Date 2022-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Sorbic Acid Propylene Glycol Water Fd&c Red No. 40 D&c Yellow No. 10 Fd&c Blue No. 1 Saccharin Carboxypolymethylene Polyethylene Glycol, Unspecified Glycerin

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-30

Description

Benzocaine 20%


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 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

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

Indications and Usage

temporarily relieves pain associated with mouth and gum irritations

Dosage and Administration

to open tube, cut 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/doctor * children under 12 years of age: adult supervision should be given in the use of this product * children under 2 years of age: do not use * for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

Description

Benzocaine 20%

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

blue 1, carbomer, flavor, glycerin, polyethylene glycol, propylene glycol, red 40, sodium saccharin, sorbic acid, water, yellow 10

Section 51945-4

Section 55105-1

Oral anesthetic

Section 55106-9

Benzocaine 20%

Section 60561-8

store at 20-25C (68-77F). Do not refrigerate.


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves pain associated with mouth and gum irritations

Dosage and Administration (34068-7)

to open tube, cut 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/doctor * children under 12 years of age: adult supervision should be given in the use of this product * children under 2 years of age: do not use * for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

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 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

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 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)

blue 1, carbomer, flavor, glycerin, polyethylene glycol, propylene glycol, red 40, sodium saccharin, sorbic acid, water, yellow 10

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral anesthetic

Section 55106-9 (55106-9)

Benzocaine 20%

Section 60561-8 (60561-8)

store at 20-25C (68-77F). Do not refrigerate.


Advanced Ingredient Data


Raw Label Data

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