PROLIDA- lidocaine hydrochloride, menthol patch 
Pronova Corp

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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Active Ingredients:

Lidocaine HCL .....................  4.00% ..................... Topical Anesthetic

Menthol ................................ 1.00% ................... External Analgesic

Topical Anesthetic

External Analgesic

USES:

For temporary relief of pain associated with minor cuts, scrapes and minor skin irritation.

WARNINGS:

  • For external use only
  • Avoid contact with eyes
  • Do not apply to open wounds or damaged skin
  • If symptoms persist for more than seven days, discontinue use and consult physician.
  • Do not bandage tightly
  • Do not use in large quantities, particularly over raw serfaces or blistererd areas.

Keep out of reach of children. If swallowed, consult a physician.

If pregnant or breast feeding, consult physician prior to use.

Directions:

  • Clean and dry afected area.
  • Remove patch from backing and apply to affected area.
  • Use only one patch at a time and a maximum of 3 patches per day.
  • Leave patch on affected area for up to 8-hours.
  • Children under 12 should consult physician prior to use.

Other Ingredients:

Acrylic acid, aluminum hydroxide, carmellose sodium, 2 ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxyno, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

For questions or comments call:

Pronova Corporation

Miami, Florida 33155

(866) 703-3508

ProlidaNEW

PROLIDA 
lidocaine hydrochloride, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67555-171
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 100 mg
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-2 (UNII: U4A966MO25)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STARCH, POTATO (UNII: 8I089SAH3T)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67555-171-1515 in 1 CARTON02/01/201509/01/2015
1100 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/201509/01/2015
Labeler - Pronova Corp (111421496)

Revised: 3/2017
 
Pronova Corp