Pain Prescriptives ME Topical Anesthetic

Pain Prescriptives 4 by

Drug Labeling and Warnings

Pain Prescriptives 4 by is a Otc medication manufactured, distributed, or labeled by Sambria Pharmaceuticals, A.I.G. Technologies, Inc., JP Packaging LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN PRESCRIPTIVES 4- lidocaine hydrochloride cream 
Sambria Pharmaceuticals

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 ME Topical Anesthetic

Active Ingredient

Lidocaine HCL 4.00% 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

​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 than 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 or 4 times daily.  Children under 2 years of age: consult a physician.  Apply in a circular motion for 50 to 60 seconds.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) 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. 54723-724-02

800-642-1096

PAIN PRESCRIPTIVES 4 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-724
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
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)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54723-724-02	2 g in 1 PACKET; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/20/2015	12/31/2019

Labeler - Sambria Pharmaceuticals (078676259)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(54723-724)

Establishment
Name	Address	ID/FEI	Business Operations
JP Packaging LLC		151369456	repack(54723-724)

Revised: 8/2018

Document Id: c38b48f3-c3e9-4f0a-89c7-138dfa2f7352

34390-5

Set id: f3ea5664-2dee-4ade-8e35-1612ee1c21af

Version: 2

Effective Time: 20180806

 

Sambria Pharmaceuticals