TETRAKAM- lidocaine and menthol patch 
Pharmaco Technology LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PDP

WARNINGS AND PRECAUTIONS

TETRAKAM 
lidocaine-menthol patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69691-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine4 g  in 100 g
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TROLAMINE (UNII: 9O3K93S3TK)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
glycerin (UNII: PDC6A3C0OX)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
water (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69691-200-15100 g in 1 BOX; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)04/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/201504/01/2015
Labeler - Pharmaco Technology LLC (079722491)

Revised: 4/2015
Document Id: 1459ab0a-5ed0-1df1-e054-00144ff8d46c
Set id: 124ef653-a119-6fe7-e054-00144ff88e88
Version: 2
Effective Time: 20150422
 
Pharmaco Technology LLC