Meijer Maximum Strength Oral Pain Relief
FDA Label NDC 41250-782

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Meijer Maximum Strength Oral Pain Relief (NDC 41250-782). 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 ingredients                           Purpose

Benzocaine 20%..............................Oral pain reliever

Benzalkonium chloride 0.1%............Antiseptic

Otc - Purpose

Use

  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

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 physician or healthcare provider

Otc - Stop Use

Stop use and ask a physician if

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

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

  • cut open tip of tube on score mark
     Adults and children 2 years of age and over                                                                                                                               Apply a small amount of product to the cavity around gum surrounding the teeth.
     Children under 12 years of age Should be supervised in the use of this product
     Children under 2 years of age Ask a physician or healthcare provider

Storage And Handling

Other information

  • 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 physician can be consulted
  • do not use continuously
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive Ingredient

Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Dosage & Administration

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Made in Korea

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