5820605 Walg 3x Gel

5820605 Walg 3x Gel
SPL v8
SPL
SPL Set ID ad509f2a-05de-6c77-e053-2995a90ae526
Route
ORAL
Published
Effective Date 2021-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-20

Description

Benzocaine 20% Menthol 0.1% Zinc chloride 0.15%


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

Dosage and Administration

cut open tip of tube on score mark * do not use if tip is cut prior to opening * 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

Description

Benzocaine 20% Menthol 0.1% 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 (1-800-222-1222).

Section 51727-6

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

Section 51945-4

Section 55105-1

Oral pain reliever

Oral pain reliever

Oral astringent

Section 55106-9

Benzocaine 20%

Menthol 0.1%

Zinc chloride 0.15%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

cut open tip of tube on score mark * do not use if tip is cut prior to opening * 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

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 (1-800-222-1222).

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral pain reliever

Oral pain reliever

Oral astringent

Section 55106-9 (55106-9)

Benzocaine 20%

Menthol 0.1%

Zinc chloride 0.15%


Advanced Ingredient Data


Raw Label Data

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