LIDOPRO- capsaicin, lidocaine, menthol, and methyl salicylate ointment

LidoPro by

Drug Labeling and Warnings

LidoPro by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Capsaicin 0.0325%

Purpose

Topical Analgesic

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Analgesic

Active Ingredient

Menthol 10%

Purpose

Topical Analgesic

Active Ingredient

Methyl Salicylate 27.5%

Purpose

Topical Analgesic

Uses:

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)

Directions

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 Ingredients

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

NDC 68788-9288-1

Made in the U.S.A.
Patent Pending

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOPRO 
capsaicin, lidocaine, menthol, and methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-9288(NDC:53225-1022)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.000325 g  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	.04 g  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	.1 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.275 g  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-9288-1	121 g in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/03/2015

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-9288)