SCALPANUMB- lidocaine cream 
Sambria Pharmaceuticals, LLC

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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Drug Facts

Active ingredient

Lidocaine 4% w/w

Purpose

External Analgesic

Uses

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

warnings

For external use only.
Avoid contact with eyes.

Do not use in large quantities, particularly over the raw surfaces or blistered area 

Stop use and ask a doctor if

condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

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.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away

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.

Questions or comments?

care@scalpashop.com

Product label

image description

SCALPANUMB 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-001
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-001-0159.14 mL in 1 TUBE; Type 0: Not a Combination Product09/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/16/2021
Labeler - Sambria Pharmaceuticals, LLC (078676259)
Establishment
NameAddressID/FEIBusiness Operations
Speciality Pharma Manufacturing, LLC013957125manufacture(54723-001)

Revised: 9/2021
Document Id: cc338a6c-01d3-7e30-e053-2995a90af168
Set id: 3c08eccb-e923-44c6-b514-38f3eca81eb2
Version: 1
Effective Time: 20210917
 
Sambria Pharmaceuticals, LLC