Your browser does not support JavaScript! LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]
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RxNorm Names

LIDOPRO (capsaicin, lidocaine, menthol, and methyl salicylate) ointment
[Terrain Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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:

  • 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
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53225-1021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.000325 g  in 1 g
LIDOCAINE (LIDOCAINE) LIDOCAINE0.045 g  in 1 g
MENTHOL (MENTHOL) MENTHOL0.10 g  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.275 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
CETYL ALCOHOL 
CHAMOMILE 
DIMETHICONE 
EDETATE DISODIUM 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:53225-1021-1121 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2012
Labeler - Terrain Pharmaceuticals (078358750)

Revised: 12/2012
Document Id: b31af1f0-b9a4-4431-9c31-7aadf4c868b2
Set id: ef3f3597-94b9-4865-b805-a84b224a207e
Version: 4
Effective Time: 20121201
 
Terrain Pharmaceuticals

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