PREDATOR- lidocaine hydrochloride cream 
Sambria Pharmaceuticals, LLC

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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Predator

Information for Patients

This product is not to be administered orally (mouth) or in the ocular (eye) area.

If used improperly by oral administration the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, any device (including hands and fingers) used to administer this product topically should be cleaned well before possible contact with eyes, intra-nasaly or mouth.

active ingredients

lidocaine HCL 4%

Other ingredients

Aqua, Amica Montana Extract, C13-14 Isoparafin, Chondrotin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth 7, Melaleuca Alternifoil (Tea Tree) oil, Methylsulfonylmethana (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

This product should be kept out of the reach of children uner twelve (12) years of age.

Pain relief

Method of Application

Rub 1ml in circular motion for 6 0seconds on effected area.

Rub 1ml in cicular motion for 60 seconds on effected area.

image description

PREDATOR 
lidocaine hcl cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-150
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 400 mg  in 1 mg
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
EMU OIL (UNII: 344821WD61)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LAURETH-7 (UNII: Z95S6G8201)  
TEA TREE OIL (UNII: VIF565UC2G)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54723-150-03 400 mg in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/11/2013
Labeler - Sambria Pharmaceuticals, LLC (078676259)
Establishment
Name Address ID/FEI Business Operations
Pure Source 969241041 manufacture(54723-150)

Revised: 2/2013
Document Id: 11d17149-b258-462f-971e-cb481a2a7e91
Set id: c0599e61-3f54-46ad-9d9c-959ca00f5014
Version: 3
Effective Time: 20130225
 
Sambria Pharmaceuticals, LLC