7 Select Oral Pain Maximum Strength Relief Gel
FDA Label NDC 10202-853

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 7-eleven, Inc. for the product 7 Select Oral Pain Maximum Strength Relief (NDC 10202-853). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.