PREDATOR- lidocaine hcl cream

Predator by

Drug Labeling and Warnings

Predator by is a Otc medication manufactured, distributed, or labeled by Sambria Pharmaceuticals, LLC, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Pain relief

Method of Application

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREDATOR 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-150
Route of Administration	TOPICAL

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)