Plush anesthetics by Sambria Pharmaceuticals, Inc. / A.I.G. Technologies, Inc. / JP Packaging LLC Plush anesthetics T

Plush anesthetics by

Drug Labeling and Warnings

Plush anesthetics by is a Otc medication manufactured, distributed, or labeled by Sambria Pharmaceuticals, Inc., A.I.G. Technologies, Inc., JP Packaging LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLUSH ANESTHETICS T- tetracaine hcl cream 
Sambria Pharmaceuticals, Inc.

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 T

​Active Ingredients

Tetracaine HCL     2% w/w

​Purpose

External Analgesic

​Uses

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

​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 then 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 to 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, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf 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  T
tetracaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54723-237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CHONDROITIN SULFATE SODIUM (BOVINE) (UNII: 8QTV3DTT8W)  
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54723-237-011.5 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, Inc. (078676259)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies, Inc.171837367manufacture(54723-237)
Establishment
NameAddressID/FEIBusiness Operations
JP Packaging LLC151369456repack(54723-237)

Revised: 8/2018
 

Trademark Results [Plush anesthetics]

Mark Image

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

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