PAINLESS TATTOO 2- lidocaine cream 
Sambria Pharmaceuticals, LLC

----------

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

External Analgesic

Uses

For temporary relief of pain and itching.

Warnings

For external use only.

Do not use onwounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Avoid contact with the eyes, rashes, or mucous membranes.

Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children and petsIf swallowed get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

Clean and dry affected area, apply to affected area not more than 3 to 4 times daily.

Children 12 years of age or younger: ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredient

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

Product label

image description

PAINLESS TATTOO 2 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-016
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)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
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 (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-016-014 mL in 1 PACKET; Type 0: Not a Combination Product09/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/26/2023
Labeler - Sambria Pharmaceuticals, LLC (078676259)

Revised: 5/2024
Document Id: 1805b184-69b1-5a39-e063-6394a90aff1b
Set id: 180b2899-7699-40e2-974a-081a6ce2bca2
Version: 3
Effective Time: 20240509
 
Sambria Pharmaceuticals, LLC