LIDOPRO by DirectRX LIDOPRO ointment

LIDOPRO by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Capsaicin 0.0325%

PURPOSE

Lidocaine HCL 4%

ACTIVE INGREDIENT

Lidocaine HCL 4%

ACTIVE INGREDIENT

Menthol 10%

ACTIVE INGREDIENT

Methyl Salicylate 27.5%

INDICATIONS & USAGE

Temporarily relieves minor aches and muscles pains associated with:

arthritis
simple back pain
strains
muscle soreness

WARNINGS

For external use only

Do not use

on open wounds, cuts, damaged or infected skin
with bandage or a heating pad
if condition worsens or symptoms persists for more than 7 days
excessive skin irritation occurs

Ask a doctor before use if

you are allergic to any ingredients, PABA, aspirin products or sulfa

When using this product

avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

Store

at 20○C - 25○C (68○F - 77○F)

DOSAGE & ADMINISTRATION

Adults 18 years and children 12 years and older:

apply product directly to affected area
product may be used as necessary, but should not be used more than four times per day.
wash hands immediately afterwards

Children 12 years or younger: ask a doctor

INACTIVE INGREDIENT

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

For Questions or Comments

Please Email info@TerrainRX.com

Manufactured for
Terrain Pharmaceuticals
Reno, NV 89501

Made in the U.S.A.
Patent Pending

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOPRO 
lidopro ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-577(NDC:53225-1022)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.04 g  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.000325 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.275 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHAMOMILE (UNII: FGL3685T2X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-577-04	121 g in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/25/2019

Labeler - DirectRX (079254320)

Registrant - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	relabel(61919-577)