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

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 B- benzocaine 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 B

​Active Ingredients

Benzocaine     20.0% 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.

​Stop use and ask 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 then 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, Caprylic/Capric Triglyceride, Cetearetj-25, Chondroitin Sulfate, Diethylhexyl Sodium Sulfosuccinate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Melaleuca alternifolia (Tea Tree) Leaf Oil, Methylfulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Safflower Oil, Stearic Acid, Triethanolamine

​Other Information

Protect this product from excessive heat or direct sun.

​Questions or Comments?

info@vinestudios.co

PLUSH ANESTHETICS  B
benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARETH-25 (UNII: 8FA93U5T67)
CHONDROITIN SULFATE SODIUM (BOVINE) (UNII: 8QTV3DTT8W)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
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)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SAFFLOWER OIL (UNII: 65UEH262IS)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54723-235-02	1.5 mg in 1 PACKET; Type 0: Not a Combination Product	11/06/2017

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

Labeler - Sambria Pharmaceuticals, Inc. (078676259)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(54723-235)

Establishment
Name	Address	ID/FEI	Business Operations
JP Packaging LLC		151369456	repack(54723-235)

Revised: 8/2018

Document Id: e7917f65-32d4-441f-8032-83fd7366189e

34390-5

Set id: 667811f6-5804-4571-8892-d44867b35a25

Version: 2

Effective Time: 20180806

 

Sambria Pharmaceuticals, Inc.