LIDOPRO by DIRECT RX LIDOPRO patch

LIDOPRO by

Drug Labeling and Warnings

LIDOPRO by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4%

Menthol 5%

Methyl Salicylate 4%

PURPOSE

Topical Analgesic

WHEN USING

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

muscle soreness

strains

sprains

arthritis

simple backache

muscle stiffness

bruises

WARNINGS

For external use only

Stomach bleeding warning

This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you

are age 60 or older

have had stomach ulcers or bleeding problems

take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)

take a blood thinning (anticoagulant) or steroid drug

have three or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Do not use

on the face or rashes; on wounds or damaged skin

in the eyes, mouth, or other mucous membranes

on genitals

with a heating pad

if allergic to any NSAIDS

right before or after heart surgery

any patch from a pouch that has been opened for 7 or more days

Ask a doctor before use if

you are allergic to topical products

the stomach bleeding warning applies to you

you are taking a diuretic

you have high blood pressure, heart disease, or kidney disease

you are pregnant

When using this product

wash hands after applying or removing patch

avoid contact with eyes. If eye contact occurs, rinse thoroughly with water

the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and consult your physician if

stomach pain or upset gets worse or lasts

rash, irritation, or itching develops

you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)

condition worsens

If pregnant or breast feeding,

ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

PURPOSE

Adults 18 years and older:

Apply patch to affected area 1 to 2 times daily or as directed.

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOPRO 
lidopro patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-582(NDC:53225-1023)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 100 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4 mg  in 100 mg
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-30 (UNII: JJX07DG188)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
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)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
ACRYLIC ACID (UNII: J94PBK7X8S)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-582-15	15 mg in 1 BOX; Type 0: Not a Combination Product	02/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/25/2019

Labeler - DIRECT RX (079254320)

Registrant - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	relabel(61919-582)