LIDOCAINE- lidocaine cream 
Sambria Pharmaceuticals Inc.

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Lidocaine Cream

Drug Facts

Active Ingredients

Lidocaine 4.0%

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 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 adulst 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. Apply in a circular motion for 30 to 60 seconds.

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. 54723-000-00 info@sambriapharma.com

Package Labeling:

Label

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-200-002 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/2020
Labeler - Sambria Pharmaceuticals Inc. (078676259)

Revised: 10/2023
Document Id: 0904f675-97c8-f3a2-e063-6394a90aa127
Set id: dbed2cc9-4928-436b-b303-e421a0e1e1f6
Version: 6
Effective Time: 20231031
 
Sambria Pharmaceuticals Inc.