Dentek Instant Pain Relief

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (10 mg)

Inactive Ingredients

Sucralose Peppermint Oil Spearmint Oil Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2002-06-20

Medication Information

Warnings and Precautions

Warnings

Allergy alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Indications and Usage

Use for the temporary relief of pain due to: . toothaches . canker sore . cold sores . sore gums

Dosage and Administration

Directions . dip applicator into liquid

Adults and children 2 years of age 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 under 12 years of age: Should be supervised in the use of this product.

Children under 2 years of age: Ask a dentist or doctor.

Description

Active ingredients 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 50566-9

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

Section 50567-7

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

Section 51727-6

Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Section 53413-1

Questions or comments? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at [email protected]

Section 55105-1

Purpose

Oral Pain Reliever

Section 55106-9

Active ingredients

Benzocaine 20%

Section 60561-8

Other information . do not use if safety seal on carton is broken. . this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. . do not use continuously

Dentek Instant Pain Relief Inner Vial Label

Dentek Instant Pain Relief Outer Carton Label

Structured Label Content

Indications and Usage (34067-9)

Use for the temporary relief of pain due to: . toothaches . canker sore . cold sores . sore gums

Dosage and Administration (34068-7)

Directions . dip applicator into liquid

Adults and children 2 years of age 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 under 12 years of age: Should be supervised in the use of this product.

Children under 2 years of age: Ask a dentist or doctor.

Warnings and Precautions (34071-1)

Warnings

Allergy alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

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

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Section 53413-1 (53413-1)

Questions or comments? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at [email protected]

Section 55105-1 (55105-1)

Purpose

Oral Pain Reliever

Section 55106-9 (55106-9)

Active ingredients

Benzocaine 20%

Section 60561-8 (60561-8)

Other information . do not use if safety seal on carton is broken. . this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. . do not use continuously

Dentek Instant Pain Relief Inner Vial Label (DenTek Instant Pain Relief Inner Vial Label)

Dentek Instant Pain Relief Outer Carton Label (DenTek Instant Pain Relief Outer Carton Label)

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"34067-9": "Use for the temporary relief of pain due to: . toothaches . canker sore . cold sores . sore gums", "34068-7": "Directions . dip applicator into liquid Adults and children 2 years of age 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 under 12 years of age: Should be supervised in the use of this product. Children under 2 years of age: Ask a dentist or doctor.", "34071-1": "Warnings Allergy alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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", "50567-7": "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", "51727-6": "Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose", "53413-1": "Questions or comments? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at info@DenTek.com", "55105-1": "Purpose Oral Pain Reliever", "55106-9": "Active ingredients Benzocaine 20%", "60561-8": "Other information . do not use if safety seal on carton is broken. . this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. . do not use continuously"}