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  5. Label Information: 7 Select Oral Pain Maximum Strength Relief

FDA Label for 7 Select Oral Pain Maximum Strength Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. INDICATIONS & USAGE
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. DOSAGE & ADMINISTRATION
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7 Select Oral Pain Maximum Strength Relief Product Label

The following document was submitted to the FDA by the labeler of this product 7-eleven, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient                                 Purpose

Benzocaine 20%.................................Oral Pain reliever


Otc - Purpose



Use for the temporary relief of pain due to toothaches


Warnings



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


Otc - Do Not Use



Do not use

  • more than directed
  • for more than 7 days unless directed by a dentist or doctor

Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.


Indications & Usage



Directions

  • remove cap and cut tip of tube on score mark
  • adults and children 2 years of age and older: apply a small amount of product to the cavity and around gum surrounding the teeth. 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

Storage And Handling



Other information

  • store at 15° to 25°C (59° to 77°F)
  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously
  • lot no. & exp. date: see package or see crimp of tube

Inactive Ingredient



Inactive ingredients glycerin, mint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol


Dosage & Administration



DISTRIBUTED BY 7-ELEVEN, INC.

Irving, TX 75063

WWW.7-ELEVEN.COM

Made in Korea


* Please review the disclaimer below.