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 Advanced Rx Pharmacy of Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient

Capsaicin 0.0325%

Purpose

Counterirritant

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Anesthetic

Active Ingredient

Menthol 10%

Purpose

Topical Analgesic

Active Ingredient

Methyl Salicylate 27.5%

Purpose

Counterirritant

Uses

For the temporary relief of joint pain and muscle pain associated with:

• Arthritis
• Simple Backache
• Muscle Sprains
• Muscle Strains

Warnings

For External Use Only

Do Not Use

• On damaged, irritated, or infected skin
  
• With a bandage or heating pad
  
• If you are allergic to any ingredients in this product

When Using This Product:

Avoid contact with eyes and mucus membranes

Stop Use and Ask a Doctor If:

• Conditions worsens
• Excessive skin irritation develops
• Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

If Pregnant orBreast-Feeding:

Ask a health professional before use.

Keep Out of Reach of Children:

If ingested seek medical help or contact a Poison Control Center immediately

Flammable:

Keep away from excessive heat or open flame

Directions

Adults and Children 12 Years of Age and Older:

• Clean and dry the affected area
• Apply product directly to your skin, up to 4 times daily affected area
• Wash hands immediately after use

Children Under 12 Years of Age: Consult physician

Other Information

• Store in a cool, dry place with lid tightly closed
• If the tamper-evident foil seal is not intact, do not use

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.

Questions or Comments?

info@terrainrx.com

HOW SUPPLIED

LidoPro Oinment is supplied as follows:

Ointent Tube of 92g NDC: 80425-0332-01

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: 80425-0332(NDC:53225-1020)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.000325 g  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.04 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
INULIN (UNII: JOS53KRJ01)
STEARIC ACID (UNII: 4ELV7Z65AP)
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80425-0332-1	92 g in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/18/2023

Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx Pharmacy of Tennessee, LLC		117023142	repack(80425-0332)