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Plush anesthetics T

Dosage form: cream
Ingredients: TETRACAINE HYDROCHLORIDE 2mg in 100mg
Labeler: Sambria Pharmaceuticals, Inc.
NDC Code: 54723-237

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 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

PLUSH ANESTHETICS  T
tetracaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-237
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
C13-14 ISOPARAFFIN 
CHONDROITIN SULFATE SODIUM (BOVINE) 
EMU OIL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE SULFATE 
ISOPROPYL PALMITATE 
LAURETH-7 
MELALEUCA ALTERNIFOLIA LEAF 
DIMETHYL SULFONE 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:54723-237-011.5 mg in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/06/2017
Labeler - Sambria Pharmaceuticals, Inc. (078676259)
Establishment
NameAddressID/FEIOperations
A.I.G. Technologies, Inc.171837367manufacture(54723-237)
Establishment
NameAddressID/FEIOperations
American Flexpack, Inc.019914600label(54723-237), pack(54723-237)

 
Sambria Pharmaceuticals, Inc.

Medically reviewed on Nov 8, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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