PAIN FREE IV- lidocaine cream 
Sambria Pharmaceuticals, LLC

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Drug Facts

Active ingredient

4% Lidocaine

Purpose

External Anesthetic

Uses

For temporary relief of pain and itching due to minor skin irritations.

Warnings

For external use only.

Avoid contact with eyes.

Do not usein large quantities, particularly over raw surface or blistered areas 

Stop use and ask doctor if

Condition worsens or if symptons persists more than 7 days or clear up and occur again within a few days. Discontinue use.

Keep out of reach of children

If 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.

Inactive ingredients

Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Other information

Protect this product from excessive heat and direct sun.

Question or Comments

FDA Registered : rico@painfree-iv.com

Other information

image description

PAIN FREE IV 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ELOSULFASE ALFA (UNII: ODJ69JZG85)  
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)  
TEA TREE OIL (UNII: VIF565UC2G)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-008-014 mL in 1 PACKET; Type 0: Not a Combination Product07/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/20/2022
Labeler - Sambria Pharmaceuticals, LLC (078676259)

Revised: 1/2024
Document Id: 0fcb13bd-6656-8bd1-e063-6394a90a70bf
Set id: 7aa4cb20-d452-417f-afdb-307df754ed75
Version: 3
Effective Time: 20240125
 
Sambria Pharmaceuticals, LLC