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  5. Label Information: Medi-derm / L With Lidocaine RX

FDA Label for Medi-derm / L With Lidocaine RX

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. INACTIVE INGREDIENT
    6. OTHER SAFETY INFORMATION
    7. OTC - QUESTIONS
    8. OTC - ASK DOCTOR
    9. PREGNANCY
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. WARNINGS
    12. OTC - DO NOT USE
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medi-derm / L With Lidocaine RX Product Label

The following document was submitted to the FDA by the labeler of this product Two Hip Consulting, 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



CAPSAICIN 0.035%

LIDOCAINE 2%

MENTHOL 5%

METHYL SALICYLATE 20%


Otc - Purpose



PURPOSE

TOPICAL ANALGESIC


Indications & Usage



USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.


Dosage & Administration



Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.


Inactive Ingredient



Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Water.


Other Safety Information



OTHER INFORMATION: STORE BELOW 90°F/32°C


Otc - Questions



QUESTIONS? 888 907-2833


Otc - Ask Doctor



IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.


Pregnancy



IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.


Warnings



WARNNGS:

FOR EXTERNAL USE ONLY.

  • USE ONLY AS DIRECTED
  • AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES
  • DO NOT USE WITH HEATING DEVICES OR PADS
  • DO NOT BANDAGE TIGHTLYIF SWALLOWED, CALL POISON CONTROL
  • IF CONTACT DOES OCCUR WITH EYES, RINSE WITH COLD WATER AND CALL A DOCTOR.

Otc - Do Not Use



DO NOT USE:

  • ON WOUNDS OR DAMAGED SKIN.
  • CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR.
  • IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.

Package Label.Principal Display Panel



Medi-Derm-L-Rx_152-14 - Medi Derm L Rx 152 14

Medi-Derm-L-Rx_152-14 - Medi Derm L Rx 152 14


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