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  5. Label Information: Lidothal Relief

FDA Label for Lidothal Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. STORAGE AND HANDLING
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidothal Relief Product Label

The following document was submitted to the FDA by the labeler of this product 19 And Pacific, Llc. 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

Menthol  1.00%

Lidocaine 4.00%


Otc - Purpose



Purpose

External analgesic

External analgesic


Indications & Usage



Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains,

bruises and sprains


Warnings



Warnings:

  • For external use only
  • Avoid contact with eyes
  • Do not apply to open wounds or damages skin
  • If symptoms persist for more than seven days, discontinue use and consult physician
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not bandage tightly
  • If pregnant or breast feeding, contact physician prior to use

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, consult physician.


Dosage & Administration



Directions:

  • Clean and dry affected area
  • Remove patch from backing and apply to affected area. Apply directly to affected area.
  • Use only on patch at a time, and a maximum of four patches per day.
  • Leave patch of affected area for up to eight hours.
  • Do not use patches for more than five consecutive days
  • Children under 12 should consult a physician prior to use.

Storage And Handling



Store at room temperature. Avoid direct sunlight.


Inactive Ingredient



Other Ingredients:

acrylic acid ,aluminum hydroxide . carmellose sodium 2-ethylexyl acrylate glycerin . isopropyl myristate .methyl acrylate

nonoxynol-30 .poluacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate strach .talc .tartaric acid

.titanium dioxide .water(254-114)


Package Label.Principal Display Panel



image description - Lido 19

image description - Lido 19


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