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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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LidoPro

Active Ingredient

Capsaicin 0.0325%

Purpose

Topical Analgesic

Active Ingredient

Lidocaine 4.5%

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:

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 20C - 25C (68F - 77F)

Directions

Adults 18 years and children 12 years and older:

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
Walnut Creek, CA 94596

Made in the U.S.A.
Patent Pending

Principal Display Panel

NDC 53225-1021-1
LidoPro
(Lidoprocin)
Topical Pain Relief Ointment
Deep Penetrating
Long Lasting
Soothing
Net WT 4 oz. (121 g)

NDC 53225-1021-1
LidoPro™
(Lidoprocin)
Topical Pain Relief Ointment
Deep Penetrating
Long Lasting
Soothing
Net WT 4 oz. (121 g)

LIDOPRO 
capsaicin, lidocaine, menthol, and methyl salicylate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53225-1021
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN .000325 g  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE .045 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .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:53225-1021-1 121 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/01/2012
Labeler - Terrain Pharmaceuticals (078358750)

Revised: 12/2014
Document Id: 079c4f1c-8356-1113-e054-00144ff8d46c
Set id: ef3f3597-94b9-4865-b805-a84b224a207e
Version: 6
Effective Time: 20141202
 
Terrain Pharmaceuticals