Pain Prescriptives LL Topical Analgesic

Pain Prescriptives Topical Analgesic by

Drug Labeling and Warnings

Pain Prescriptives Topical Analgesic 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]

PAIN PRESCRIPTIVES TOPICAL ANALGESIC LL- 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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Pain Prescriptives LL Topical Analgesic

​Active Ingredients

Tetracaine HCL     2.0% 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.

​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?

FDA Registered: NDC No. 54723-725-03

800-642-1096

PAIN PRESCRIPTIVES TOPICAL ANALGESIC  LL
tetracaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE HYDROCHLORIDE	20 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54723-725-03	1500 mg in 1 PACKET; Type 0: Not a Combination Product	07/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2016	12/31/2019

Labeler - Sambria Pharmaceuticals, Inc. (078676259)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(54723-725)

Establishment
Name	Address	ID/FEI	Business Operations
JP Packaging LLC		151369456	repack(54723-725)

Revised: 8/2018

Document Id: 7dd209c5-9fc4-48a2-8ddc-036209131397

34390-5

Set id: 8525e896-f367-4228-a158-16787191af31

Version: 2

Effective Time: 20180806

 

Sambria Pharmaceuticals, Inc.