5820321 Cvs Max Str Oral Pain Reliever Paste

5820321 Cvs Max Str Oral Pain Reliever Paste
SPL v13
SPL
SPL Set ID 8691d6b6-741e-47b2-8332-76742b34715f
Route
TOPICAL
Published
Effective Date 2012-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Menthol Petrolatum Gelatin Polyethylene Glycol 1000 Saccharin Methyl Salicylate Pectin Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-01-20

Description

Benzocaine 20%

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Benzocaine 20%

Use

for the temporary relief of pain due to

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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 the eyes
  • do not use more than directed
  • do not use for more than 7 days unless directed by a dentist or doctor.
Section 51945-4

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

Directions
  • cut open tip of tube on scoremark
  • 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
Active Ingredient

Benzocaine 20%

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 tempory expedient until a dentist can be consulted. Do not use continuously. This formula will stay in place for extended duration of relief.

Inactive Ingredients

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


Structured Label Content

Use

for the temporary relief of pain due to

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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 the eyes
  • do not use more than directed
  • do not use for more than 7 days unless directed by a dentist or doctor.
Section 51945-4 (51945-4)

Purpose

Oral pain reliever

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

Directions
  • cut open tip of tube on scoremark
  • 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
Active Ingredient (Active ingredient)

Benzocaine 20%

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 tempory expedient until a dentist can be consulted. Do not use continuously. This formula will stay in place for extended duration of relief.

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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