5820388 Family Wellness Max Str Oral Pain Relief

5820388 Family Wellness Max Str Oral Pain Relief
SPL v7
SPL
SPL Set ID ddd0a678-3cee-42a1-a34e-a870e2dd4a4f
Route
ORAL
Published
Effective Date 2018-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH NOT FINAL Completed Since 2013-08-01 Until 2023-03-23

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin(cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

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

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: do not use

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 (68-77F)

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

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
  • allergic reaction occurs
Section 50570-1

Do not use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
  • for teething
  • in children under 2 years of age
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

FAMILY WELLNESS

MAXIMUM STRENGTH

Oral Pain Relief

20% Benzocaine

Liquid Anesthetic

0.5 FL OZ (14.7 mL)

Section 55105-1

Purpose

Oral anesthetic

Section 55106-9

Active ingredient

Benzocaine 20% (W/W)


Structured Label Content

Indications and Usage (34067-9)

Use

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: do not use

Warnings and Precautions (34071-1)

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin(cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

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 (68-77F)

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

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
  • allergic reaction occurs
Section 50570-1 (50570-1)

Do not use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
  • for teething
  • in children under 2 years of age
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)

FAMILY WELLNESS

MAXIMUM STRENGTH

Oral Pain Relief

20% Benzocaine

Liquid Anesthetic

0.5 FL OZ (14.7 mL)

Section 55105-1 (55105-1)

Purpose

Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20% (W/W)


Advanced Ingredient Data


Raw Label Data

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