5820344 Top Care Oral Pain Relief Liquid

SPL v14

SPL

SPL Set ID 6586fcda-b232-46b4-8461-c0042a4127c6

Route

ORAL

Published

Effective Date 2019-03-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (20 g)

Inactive Ingredients

Polyethylene Glycol 400 Saccharin Sodium Propylene Glycol Methylparaben Benzyl Alcohol Water Fd&c Red No. 40 D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-10-01

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

toothache
sore gums
canker sores
braces
minor dental procedures

Dosage and Administration

Directions

Adults and children 2 years of age and older:
apply to affected area using applicator tip
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: consult a dentist or doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

do not use if package has been opened
store at 20 - 25°C (68-77°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask doctor or dentist if

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

Section 50567-7

When using this product

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

Section 51727-6

Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Section 51945-4

Section 55105-1

Purpose

Oral anesthetic

Section 55106-9

Active ingredient

Benzocaine 20.0% (w/w)

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

toothache
sore gums
canker sores
braces
minor dental procedures

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:
apply to affected area using applicator tip
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: consult a dentist or doctor

Warnings and Precautions (34071-1)

Warnings

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

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

do not use if package has been opened
store at 20 - 25°C (68-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor or dentist if

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

Section 50567-7 (50567-7)

When using this product

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

Section 51727-6 (51727-6)

Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20.0% (w/w)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures", "34068-7": "Directions Adults and children 2 years of age and older: apply to affected area using applicator tip 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: consult a dentist or doctor", "34071-1": "Warnings 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", "42229-5": "Drug Facts", "44425-7": "Other information do not use if package has been opened store at 20 - 25°C (68-77°F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops", "50567-7": "When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor", "51727-6": "Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water", "55105-1": "Purpose Oral anesthetic", "55106-9": "Active ingredient Benzocaine 20.0% (w/w)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:44.555762 · Updated: 2026-03-14T23:09:41.311223