MEDI-DERM / L WITH LIDOCAINE- methyl salicylate, menthol, capsaicin and lidocaine cream 
Two Hip Consulting, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CAPSAICIN 0.035%

LIDOCAINE 2%

MENTHOL 5%

METHYL SALICYLATE 20%

PURPOSE

TOPICAL ANALGESIC

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.

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 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 INFORMATION: STORE BELOW 90°F/32°C

QUESTIONS? 888 907-2833

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.

IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

KEEP OUT OF REACH OF CHILDREN.

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.

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.

image description

MEDI-DERM / L  WITH LIDOCAINE
methyl salicylate menthol capsaicin lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76074-132
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.0355 g  in 100 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76074-132-14120 mL in 1 TUBE; Type 0: Not a Combination Product08/18/201203/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/18/201203/28/2016
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 4/2016
 
Two Hip Consulting, LLC