Lidopro by Direct_Rx Lidopro Ointment

Lidopro by

Drug Labeling and Warnings

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

Drug Details [pdf]

LIDOPRO- lidopro ointment ointment 
Direct_Rx

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Lidopro Ointment

Capsaicin 0.0325%

Counterirritant

Lidocaine HCL 4%

Topical Anesthetic

Menthol 10%

Topical Analgesic

Methyl Salicylate 27.5%

Counterirritant

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

Arthritis
Simple Backache
Muscle Sprains
Muscle Strains

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

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

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

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.

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

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

LIDOPRO 
lidopro ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-393(NDC: 53225-1020)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
INULIN (UNII: JOS53KRJ01)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHAMOMILE (UNII: FGL3685T2X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-393-31	92 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2022	12/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/16/2022	12/06/2023

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct_Rx		079254320	relabel(72189-393)

Revised: 12/2023

Document Id: 0bc8f9ba-0cd9-a634-e063-6294a90aac0d

34390-5

Set id: f2561493-d181-3aa9-e053-2a95a90a83cb

Version: 4

Effective Time: 20231205