5820337 Walgreens Max Str Oral Anesthetic Paste

5820337 Walgreens Max Str Oral Anesthetic Paste
SPL v14
SPL
SPL Set ID 2ef0eb2c-b614-44e2-b9b3-97b02c654977
Route
TOPICAL
Published
Effective Date 2013-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Menthol Petrolatum Gelatin Polyethylene Glycol, Unspecified Saccharin Methyl Salicylate Pectin Carboxymethylcellulose Sodium, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-08-01

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

Use for the temporary relief of pain due to:

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Dosage and Administration

Directions

  • cut open tip of tube on score mark
  • adults and children 2 years of age and older: apply to the affected area 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
  • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
Description

Drug Facts

Section 42229-5

Drug Facts

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

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Section 50567-7

When using this product

  • avoid contact with eyes
  • do not use more than directed
  • do not use for more than 7 days unless told to do so by a dentist or doctor.
Section 51727-6

Inactive ingredients Cellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.

Section 51945-4

Section 55105-1

Purpose

Oral pain reliever

Section 55106-9

Active ingredient

Benzocaine 20%

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 until a dentist can be consulted. Do not use continuously.


Structured Label Content

Indications and Usage (34067-9)

Use for the temporary relief of pain due to:

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Dosage and Administration (34068-7)

Directions

  • cut open tip of tube on score mark
  • adults and children 2 years of age and older: apply to the affected area 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
  • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
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 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

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not use more than directed
  • do not use for more than 7 days unless told to do so by a dentist or doctor.
Section 51727-6 (51727-6)

Inactive ingredients Cellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral pain reliever

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20%

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 until a dentist can be consulted. Do not use continuously.


Advanced Ingredient Data


Raw Label Data

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