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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54723-237
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE HYDROCHLORIDE	2 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54723-237-01	1.5 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, Inc. (078676259)

Name	Address	ID/FEI	Business Operations
Establishment
A.I.G. Technologies, Inc.		171837367	manufacture(54723-237)

Name	Address	ID/FEI	Business Operations
Establishment
JP Packaging LLC		151369456	repack(54723-237)

Revised: 8/2018

Document Id: 1f548d3e-c4af-4073-8eb8-e6cd5f0a4099

Set id: 48269b67-8b08-466d-963d-b214a4254618

Version: 2

Effective Time: 20180806

Sambria Pharmaceuticals, Inc.

Plush anesthetics T

​Active Ingredients

​Purpose

​Uses

​Directions

​Inactive Ingredients

​Other Information