Label: PREDATOR- lidocaine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54723-101-02 - Packager: Sambria Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 13, 2013
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- Official Label (Printer Friendly)
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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
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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
- PURPOSE
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
PREDATOR
lidocaine hydrochloride creamProduct 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)