Your browser does not support JavaScript! PREDATOR (LIDOCAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, LLC]
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PREDATOR (lidocaine hcl) cream
[Sambria Pharmaceuticals, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54723-150
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE400 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
C13-14 ISOPARAFFIN 
CHONDROITIN SULFATE (BOVINE) 
EMU OIL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE SULFATE 
ISOPROPYL PALMITATE 
LAURETH-7 
TEA TREE OIL 
DIMETHYL SULFONE 
PHENOXYETHANOL 
POLYACRYLAMIDE (10000 MW) 
PROPYLENE GLYCOL 
STEARIC ACID 
TRIETHANOLAMINE BENZOATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-150-03400 mg in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/11/2013
Labeler - Sambria Pharmaceuticals, LLC (078676259)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture(54723-150)

Revised: 2/2013
 
Sambria Pharmaceuticals, LLC

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