5820346 Dg Max Str Op Relief Liq

5820346 Dg Max Str Op Relief Liq
SPL v11
SPL
SPL Set ID 8f6e2780-cfb7-4bef-9b7d-13cb80d8923e
Route
ORAL
Published
Effective Date 2015-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Saccharin Sodium Methylparaben Benzyl Alcohol Fd&c Red No. 40 D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-01

Description

Benzocaine 20.0% ..................................Purpose: Oral pain reliever


Medication Information

Warnings and Precautions

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

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.

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 swelling rash or fever developes

Dosage and Administration

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

Benzocaine 20.0% ..................................Purpose: Oral pain reliever

Uses

Temporarily relieves pain associated with the following mouth irritations  toothache sore gums canker sores braces minor dental procedures

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 51945-4

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.

Active Ingredient

Benzocaine 20.0% ..................................Purpose: Oral pain reliever

Other Information

Do not use if package has been opened

Store at 20-25°C (68-77°F)

Inactive Ingredients

Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Methylparaben, Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water


Structured Label Content

Uses

Temporarily relieves pain associated with the following mouth irritations  toothache sore gums canker sores braces minor dental procedures

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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

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.

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 swelling rash or fever developes

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 51945-4 (51945-4)

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.

Active Ingredient (Active ingredient)

Benzocaine 20.0% ..................................Purpose: Oral pain reliever

Other Information

Do not use if package has been opened

Store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Methylparaben, Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water


Advanced Ingredient Data


Raw Label Data

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