5820364 walgreens instant oral pain relief liquid

5820364 walgreens instant oral pain relief liquid
SPL v14
SPL
SPL Set ID 8f24309d-d393-455a-a9a5-a55344adf36b
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
benzyl alcohol fd&c red no. 40 d&c yellow no. 10 fd&c blue no. 1 water polyethylene glycol, unspecified propylene glycol saccharin sodium methylparaben

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
otc monograph drug active Since 2015-01-01

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

Active Ingredient

Active ingredient

Benzocaine 20.0% (w/w)

Indications and Usage

Uses

Temporarily relieves pain associated with the following mouth 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 affect4ed 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: ask 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
  • tore 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 a 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 more than directed 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 Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Section 51945-4

Section 55105-1

Purpose

Oral anesthetic


Structured Label Content

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

Active Ingredient (55106-9)

Active ingredient

Benzocaine 20.0% (w/w)

Indications and Usage (34067-9)

Uses

Temporarily relieves pain associated with the following mouth 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 affect4ed 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: ask a dentist or doctor.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • do not use if package has been opened
  • tore 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 a 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 more than directed 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 Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral anesthetic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)