Your browser does not support JavaScript! DOLORACIN RX (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) CREAM [TWO HIP CONSULTING, LLC]
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DOLORACIN RX (methyl salicylate, menthol and capsaicin) cream
[Two Hip Consulting, LLC]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

DoloraCin-Rx_141-14_LBL

DOLORACIN  RX
methyl salicylate, menthol and capsaicin cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:76074-141
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE20 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL5 g  in 100 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN0.035 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76074-141-14120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/11/2013
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 9/2013
 
Two Hip Consulting, LLC

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