Being Well Extra Strength Menthol Heat
FDA Label NDC 46994-851

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Save-a-lot Food Stores, Ltd. for the product Being Well Extra Strength Menthol Heat (NDC 46994-851). 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 5.0%......................................................Topical Analgesic Patch

Otc - Purpose

Uses For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

Warnings for external use only

Otc - When Using

When using this product

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center immediately

Indications & Usage

Directions

  • Adults and children 12 years of age and over: apply to affected area, not 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 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, Disodium Edatate, Gelatin, Kaolin, Methylparaben, Polysorbate 80, Titanium Dioxide, Isopropyl Myristate, Purified Water, Polyvinyl Pyrrolidone, Polyvinyl Alcohol, Glycerin, Magnesium Aluminometasilicate, Caster Oil, Tartaric Acid, Polyethylene Glyco Monostearate, Sodium Polyacrylate, BHT, Tocopherol Acetate

Dosage & Administration

Distributed By:

Save-A-Lot Food Stores, Ltd.

100 Corporate Office Dr.

Earth City, MO 63045

Product of Korea

Package Label.Principal Display Panel

Image Of Carton Label (Bwmentholheatpatch)

Image Of Carton Label (Bwmentholheatpatch)

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