Assured Pain Relief Hot Menthol
FDA Label NDC 33992-6156

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc for the product Assured Pain Relief Hot Menthol (NDC 33992-6156). 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 - when using, otc - stop use, otc - keep out of reach of children, indications & usage, inactive ingredient, 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

Menthol 30mg--------------------------------------------------------- Topical analgestic

Capsicum extract (capsaicin) 8.3mg--------------------------------- Topical analgestic

Otc - Purpose

Uses  Temporarily relieves minor pain associated with:

  • arthritis
  • simple backche
  • bursitis
  • tendonitis
  • muscle strains
  • music sprains
  • bruises
  • cramps

Warnings

For external use only

  • If pregnant or breast feeding, ask a health professional before use.

Otc - When Using

When using this product

  • use as only directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops
  • do not apply to wounds or damanged skin

Otc - Keep Out Of Reach Of Children

Keep out of reach of chidren.

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

  • Adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily.
  • Children under 12 years of age: do not use, consult a doctor.
  • For easy application: partially peel back protective film and apply exposed film and apply exposed patch to site of pain.
  • Carefully remove remaining film while pressing patch to skin for secure adhesion.

Inactive Ingredient

Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, tatanium dioxide, tocopherol acetate

Release liner: polypropylene, non-woven material: polyester non-woven fabric

Dosage & Administration

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN KOREA

* Please review the disclaimer below.