Medi-derm
FDA Label NDC 76074-151

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Two Hip Consulting, Llc for the product Medi-derm (NDC 76074-151). 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, indications & usage, warnings, otc - do not use, dosage & administration, inactive ingredient, other safety information, 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                             

Capsaicin 0.035%
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.

Warnings

Warnings: 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 cover or bandage tightly.
  • If 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.

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.

Package Label.Principal Display Panel

Medi-derm-rx_151-14 (Medi Derm Rx 151 14)

Medi-derm-rx_151-14 (Medi Derm Rx 151 14)

* Please review the disclaimer below.