MEDI-PATCH WITH LIDOCAINE RX- capsaicin, lidocaine, menthol, and methyl salicylate patch

MEDI-PATCH WITH LIDOCAINE by

Drug Labeling and Warnings

MEDI-PATCH WITH LIDOCAINE by is a Prescription medication manufactured, distributed, or labeled by Two Hip Consulting, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

CAPSAICIN 0.035%

LIDOCAINE 0.5%

MENTHOL 5%

METHYL SALICYLATE 20%

PURPOSE

PURPOSE

TOPICAL ANALGESIC

TOPICAL ANESTHETIC

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients: ACRLIC 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 SAFETY INFORMATION

OTHER INFORMATION: STORE BELOW 90°F/32°C

QUESTIONS

QUESTIONS? 888 907-2833

ASK DOCTOR

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.

PREGNANCY

IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDI-PATCH WITH LIDOCAINE  RX
capsaicin, lidocaine, menthol, and methyl salicylate patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76074-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0175 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.25 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76074-153-41	1 in 1 POUCH
1	NDC: 76074-153-21	1 in 1 PATCH
2	NDC: 76074-153-51	5 in 1 BOX
2	NDC: 76074-153-21	1 in 1 PATCH

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)