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

packet

PAIN PRESCRIPTIVES TOPICAL ANALGESIC  LL
tetracaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54723-725
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE20 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54723-725-031500 mg in 1 PACKET; Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/201612/31/2019
Labeler - Sambria Pharmaceuticals, Inc. (078676259)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies, Inc.171837367manufacture(54723-725)
Establishment
NameAddressID/FEIBusiness Operations
JP Packaging LLC151369456repack(54723-725)

Revised: 8/2018
 
Sambria Pharmaceuticals, Inc.