SPL v6
SPL
SPL Set ID a471a858-edbf-c31e-e053-2995a90a7156
Route
ORAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-18

Description

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 methoglobinemia, 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 immeditate 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

Description

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

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 50570-1

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 51727-6

Inactive ingredients ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

Section 51945-4

4x Medicated

Toothache & Gum

Relief Gel

*20'% Benzocaine to relieve oral pain

*Kills harmful bacteria

*Astringent to help prevent infection

*Cools gumm and relieves irritation

Fast Acting Gel

Compare to Orajel 4x Medicated for Toothache and Gum Gel Active Ingredients

Section 55105-1

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

Section 55106-9

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

Other information * 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 untill 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

Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount 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

Allergy Alert

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


Structured Label Content

Warnings and Precautions (34071-1)

Methemoglobinemia warning: use of this product may cause methoglobinemia, 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 immeditate 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

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 50570-1 (50570-1)

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 51727-6 (51727-6)

Inactive ingredients ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

Section 51945-4 (51945-4)

4x Medicated

Toothache & Gum

Relief Gel

*20'% Benzocaine to relieve oral pain

*Kills harmful bacteria

*Astringent to help prevent infection

*Cools gumm and relieves irritation

Fast Acting Gel

Compare to Orajel 4x Medicated for Toothache and Gum Gel Active Ingredients

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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)

Other information * 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 untill 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

Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount 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

Allergy Alert (Allergy alert)

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


Advanced Ingredient Data


Raw Label Data

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