PLUSH ANESTHETICS L- lidocaine hydrochloride cream 
Sambria Pharmaceuticals

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.

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Plush anesthetics L

Active Ingredient

Lidocaine HCL 4% w/w

Purpose

External Analgesic

Uses

For temporary relief of pain and itching due to minor skin irritation.

Warnings

​For external use only. Avoid contact with Eyes.

​Do not use​ in large quantities, particularly over raw surfaces or blistered areas

​Stop use and ask a doctor if

• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.  Discontinue use.

​Keep out of reach of children

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.  Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

​Other Information

Protect this product from excessive heat and direct sun.

​Questions or Comments?

info@vinestudios.co

packet

PLUSH ANESTHETICS  L
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-236
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
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)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-236-012 mg in 1 PACKET; Type 0: Not a Combination Product11/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/06/201712/31/2019
Labeler - Sambria Pharmaceuticals (078676259)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies, Inc.171837367manufacture(54723-236)
Establishment
NameAddressID/FEIBusiness Operations
JP Packaging LLC151369456repack(54723-236)

Revised: 8/2018
 
Sambria Pharmaceuticals