PREDATOR- lidocaine hydrochloride cream

Predator by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Lidocaine HCL

Purpose

Topical Pain Reliever

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprains

Warnings

For external use only

Ask a doctor before you use if

you have sensitive skin, renal (kidney) and/or hepatic (liver) dysfunction

When using this product

• Avoid contact with the eyes or mucous membranes
• Do not apply to wounds or damaged skin
• Do not use with other ointments, creams, sprays or liniments
• Do not apply to irritated skin or if excessive irritation develops
• Do not bandage
• Wash hands after use with soap and water

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of the reach of children

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 6 years of age and older: Rub a thin film over affected areas not more than 4 times daily; rigorously rub product onto affected area in a circular motion for 30 to 60 seconds.
• Children under 6 years of age: Consult a physician

Flammable

Keep away from excessive heat or open flame

Storage

Store in a cool dry place with lid closed tightly.

Inactive ingredients

Polyacrylamide and C13-14 Isoparrafin and Laureth-7, Methylsulfonylmethane, Ethoxydiglycol, Propylene Glycol, Triethanolamine, Emu Oil, Tea Tree Oil, Arnica Montana Extract, Ethylhexylglycerin, Phenoxyethanol, Isopropyl Palmitate, Stearic Acid, Glucosamine Sulfate, Chondroitin Sulfate

Questions or Comments

1-888-246-6601

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INGREDIENTS AND APPEARANCE

PREDATOR 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
BIS-ETHOXYDIGLYCOL SUCCINATE (UNII: YGQ120RH3I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
EMU OIL (UNII: 344821WD61)
TEA TREE OIL (UNII: VIF565UC2G)
ARNICA MONTANA (UNII: O80TY208ZW)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54723-100-11	1 in 1 CARTON
1	NDC: 54723-100-01	30 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2012

Labeler - Sambria Pharmaceuticals, LLC (078676259)