DOLOR-PARCHE WITH LIDOCAINE-RX- capsaicin, lidocaine, menthol, and methyl salicylate patch 
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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CAPSAICIN 0.035%

LIDOCAINE 0.5%

MENTHOL 5%

METHYL SALICYLATE 20%

PURPOSE

TOPICAL ANALGESIC

TOPICAL ANESTHETIC

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 AS DIRECTED. PRIOR TO USE, CLEAN AND DRY AFFECTED AREA. REMOVE PROTECTIVE FILM AND APPLY DIRECTLY TO AFFECTED AREA. DO NOT USE MORE THAN 3 TIMES A DAY. THOROUGHLY WASH HANDS AFTER APPLICATION. RESEAL POUCH AFTER OPENING.

Inactive Ingredients: ACRYLIC ACID, ALUMINUM HYDROXIDE, CARMELLOSE SODIEM, 2-ETHYLHEXYL ACRYLATE, GLYCERIN, ISOPROPYL MYRISTATE, METHYL ACRYLATE, NONOXYNOL-30, POLYACRYLATE, POLYACRYLIC ACID, POLYSORBATE 80, SORBITAN SESQUIOLEATE, STARCH, TALC, TARTARIC ACID, TITANIUM DIOXIDE, 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.

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.

Dolor-Parche-Rx_143-21

DOLOR-PARCHE  WITH LIDOCAINE-RX
capsaicin, lidocaine, menthol, and methyl salicylate patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76074-143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.035 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76074-143-211 in 1 PATCH; Type 0: Not a Combination Product07/31/201304/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/31/201305/31/2016
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 5/2016
 
Two Hip Consulting, LLC