Topical Pain Relief Rx

Generic Name: methyl salicylate menthol capsaicin
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredients                             

Capsaicin 0.035%
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.

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

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.

TOPICAL PAIN RELIEF  RX
methyl salicylate menthol capsaicin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76074-140
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 20 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL 5 g  in 100 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN .0355 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER 934  
CETOSTEARYL ALCOHOL  
CYPERUS ESCULENTUS LEAF  
GLYCERYL MONOSTEARATE  
FD&C GREEN NO. 3  
HYPROMELLOSE 2208 (100000 MPA.S)  
ISOPROPYL PALMITATE  
METHYLISOTHIAZOLINONE  
PHENOXYETHANOL  
POLYSORBATE 60  
PROPYLENE GLYCOL  
SODIUM HYDROXIDE  
STEARYL ALCOHOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:76074-140-14 120 mL in 1 TUBE
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)
Revised: 08/2013
 
Two Hip Consulting, LLC



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