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Lidozen by Proficient Rx LP

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 40mg in 1mL, MENTHOL, UNSPECIFIED FORM 10mg in 1mL
Labeler: Proficient Rx LP
NDC Code: 63187-892

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.

Lidozen Gel

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%

Menthol 1.00%

Topical Anesthetic

External Analgesic

USES:

For temporary relief of pain

WARNINGS:
For external use only.
Avoid contact with eyes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
​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.

DIRECTIONS (Adults and Children Over 12 Years):

Apply directly to affected area. Do not use more than four times per day.

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5

Package Labeling:

Manufactured for:

Village Pharma LLC

Agoura Hills, CA 91301

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

LIDOZEN 
lidocaine hydrochloride, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-892(NDC:71574-300)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE40 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
ARNICA MONTANA 
INDIAN FRANKINCENSE 
GREEN TEA LEAF 
CARBOXYPOLYMETHYLENE 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
TROLAMINE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
ISOPROPYL MYRISTATE 
POLYETHYLENE GLYCOL 400 
PHENOXYETHANOL 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
Packaging
#Item CodePackage Description
1NDC:63187-892-721 BOTTLE in 1 BOX
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/22/2017
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-892)

 
Proficient Rx LP

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Medically reviewed on Aug 1, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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