Plush anesthetics by Sambria Pharmaceuticals / A.I.G. Technologies, Inc. / American Flexpack, Inc. Plush anesthetics L

Drug Details [pdf]

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.

----------

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-236
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1000 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 54723-236-01	2 mg in 1 PACKET; Type 0: Not a Combination Product	11/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/06/2017	12/31/2019

Labeler - Sambria Pharmaceuticals (078676259)

Name	Address	ID/FEI	Business Operations
Establishment
A.I.G. Technologies, Inc.		171837367	manufacture(54723-236)

Name	Address	ID/FEI	Business Operations
Establishment
JP Packaging LLC		151369456	repack(54723-236)

Revised: 8/2018

Document Id: a1ef416f-dea0-4dad-804d-20849484c573

Set id: 22fa42a4-00e7-4694-bbfb-4236377f7687

Version: 3

Effective Time: 20180806

Trademark Results [Plush anesthetics]

Mark Image Registration \| Serial	Company Trademark Application Date
PLUSH ANESTHETICS 87763460 not registered Dead/Abandoned	Plush Anesthetics LLC 2018-01-20