PREDATOR- lidocaine hydrochloride 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]

WARNINGS

For external use only

Avoid contact with eyes

If symptoms persist for more than seven days, or clear up and occur again within a few days, discontinue use and consult physician

If redness, irritation, swelling, pain or ot5her symptoms increase, discontinue use and consult physician

If swallowed consult physician.

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

Keep out of reach of children

PURPOSE

External anesthetic

DOSAGE & ADMINISTRATION

For adults and children two years or older, apply externally to the affected area. Do not use more than three to four times per day.

Uses

For temporary relief of pain and itching and minor skin irratations due to minor cuts and scrapes, sunburn and minor burns. Also used for temporary relief of itching associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak and poison sumac, soaps, detergetns, cosmetics and jewelry.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREDATOR 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-101
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: 54723-101-02	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(54723-101)