Dentek Instant Pain Relief

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (200 mg)

Inactive Ingredients

Peppermint Oil Polyethylene Glycol 400 Spearmint Oil Sucralose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2015-07-31

Medication Information

Purpose

Oral pain reliever

Description

Drug Facts

Use

for the temporary relief of pain due to:

toothaches
canker sores
cold sores
sore gums

Section 42229-5

Drug Facts

Warnings

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.

Directions

dip applicator into liquid

Adults and children 2 years and older	Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
Children between 2 and 12 years	Should be supervised in the use of this product.
Children under 2 years	Do not use.

Do Not Use

for teething
in children under 2 years of age

Active Ingredient

Benzocaine 20%

Other Information

for toothaches, use only as a temporary remedy until a dentist can be seen
store at 20-25⁰C (68-77⁰F).

Inactive Ingredients

Peppermint Oil, Polyethylene Glycol 400, Spearmint Oil, Sucralose

Principal Display Panel

Den T ek ™

INSTANT PAIN RELIEF

Benzocaine 20% / ORAL ANESTHETIC

1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

When Using This Product

avoid contact with the eyes
do not exceed recommended dosage
do not use for more than 7 days unless directed by a doctor/dentist

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Dentist Or Doctor If

swelling, rash or fever develops
irritation, pain or redness persists or worsens
symptoms do not improve in 7 days

Structured Label Content

Use

for the temporary relief of pain due to:

toothaches
canker sores
cold sores
sore gums

Section 42229-5 (42229-5)

Drug Facts

Purpose

Oral pain reliever

Warnings

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.

Directions

dip applicator into liquid

Adults and children 2 years and older	Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
Children between 2 and 12 years	Should be supervised in the use of this product.
Children under 2 years	Do not use.

Do Not Use (Do not use)

for teething
in children under 2 years of age

Active Ingredient (Active ingredient)

Benzocaine 20%

Other Information (Other information)

for toothaches, use only as a temporary remedy until a dentist can be seen
store at 20-25⁰C (68-77⁰F).

Inactive Ingredients (Inactive ingredients)

Peppermint Oil, Polyethylene Glycol 400, Spearmint Oil, Sucralose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Den T ek ™

INSTANT PAIN RELIEF

Benzocaine 20% / ORAL ANESTHETIC

1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

When Using This Product (When using this product)

avoid contact with the eyes
do not exceed recommended dosage
do not use for more than 7 days unless directed by a doctor/dentist

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Dentist Or Doctor If (Stop use and ask a dentist or doctor if)

swelling, rash or fever develops
irritation, pain or redness persists or worsens
symptoms do not improve in 7 days

Advanced Ingredient Data

[{"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "2.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "784.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SPEARMINT OIL", "unii": "C3M81465G5", "classCode": "IACT", "strengthNumerator": "3.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "for the temporary relief of pain due to: toothaches canker sores cold sores sore gums", "42229-5": "Drug Facts", "Purpose": "Oral pain reliever", "Warnings": "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.", "Directions": "dip applicator into liquid Adults and children 2 years and older Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children between 2 and 12 years Should be supervised in the use of this product. Children under 2 years Do not use. ", "Do not use": "for teething in children under 2 years of age", "Active ingredient": "Benzocaine 20%", "Other information": "for toothaches, use only as a temporary remedy until a dentist can be seen store at 20-25⁰C (68-77⁰F).", "Inactive ingredients": "Peppermint Oil, Polyethylene Glycol 400, Spearmint Oil, Sucralose ", "PRINCIPAL DISPLAY PANEL": "Den T ek ™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE ", "When using this product": "avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Stop use and ask a dentist or doctor if": "swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information