PUROXCIN- lidocaine hydrochloride and menthol liquid 
Pharmaceutics Corporation

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.

----------

Puroxcin

Puroxcin

Active Ingredients:

Lidocaine HCL 4.00%

Menthol 1.00%

Purpose

Topical Analgesic

External Analgesic

Uses:

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

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.

Keep out of reach of children.

If swallowed, consult physician.

  • Do not bandage tightly
  • If pregnant or breast feeding, contact physician prior to use.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

Directions

  • Clean and dry affected area.
  • Remove patch from backing and apply to affected area.
  • Use only one patch at a time, and maximum of four patches/day.
  • Leave patch on affected area for up to 8-hours.
  • Do not use patches for longer than five consecutive days.
  • Children under 12 should consult physician prior to use.

Other 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, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD C Blue 1, FD C Yellow 5.

Store below 25 degrees. Avoid direct sunlight.

Manufactured For:

Pharmaceutics Corporation

Glendale, CA 91204

For Questions or Comments please call 877-328-259

labellabel

PUROXCIN 
lidocaine hydrochloride, menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49430-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA (UNII: O80TY208ZW)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49430-007-1515 in 1 BOX
117 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:49430-007-3030 in 1 BOX
217 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/201410/15/2015
Labeler - Pharmaceutics Corporation (079132026)
Establishment
NameAddressID/FEIBusiness Operations
Zhuhai Guojia New Macromolecule Material Co., LTD679871251manufacture(49430-007)

Revised: 9/2015
 
Pharmaceutics Corporation