MEDI-DERM
95910cee-0a43-4ac9-aeb9-6a659757b3ba
HUMAN PRESCRIPTION DRUG LABEL
Feb 6, 2019
Two Hip Consulting, LLC
DUNS: 965352896
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHYL SALICYLATE, MENTHOL AND CAPSAICIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (17)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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 SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Capsaicin 0.035%
Menthol 5%
Methyl Salicylate 20%
OTC - PURPOSE SECTION
PURPOSE
TOPICAL ANALGESIC
WARNINGS SECTION
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 SECTION
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.
INACTIVE INGREDIENT SECTION
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 SECTION
QUESTIONS? 888 907-2833
OTC - ASK DOCTOR SECTION
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 SECTION
IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.