MEDI-DERM RX- methyl salicylate, menthol and capsaicin cream

MEDI-DERM by

Drug Labeling and Warnings

MEDI-DERM by is a Prescription medication manufactured, distributed, or labeled by Two Hip Consulting, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                             

Capsaicin 0.035%
Menthol 5%
Methyl Salicylate 20%

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.

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

QUESTIONS

QUESTIONS? 888 907-2833

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDI-DERM  RX
methyl salicylate, menthol and capsaicin cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76074-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.035 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYPERUS ESCULENTUS LEAF (UNII: T1004HC0OF)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76074-151-14	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/18/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/18/2012

Labeler - Two Hip Consulting, LLC (965352896)

Registrant - Two Hip Consulting, LLC (965352896)