DOLORACIN RX- methyl salicylate, menthol and capsaicin cream 
Two Hip Consulting, LLC

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.

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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.

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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76074-141
Route of Administration TOPICAL DEA Schedule     
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 934 (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:76074-141-14 120 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/11/2013
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 9/2013
Document Id: 1f39b89b-a8c3-440a-a253-4ad20cdfd28a
Set id: ce4747e3-d8a4-48e6-910f-0f287c0c38fd
Version: 3
Effective Time: 20130909
 
Two Hip Consulting, LLC