SOLE SERUM- lidocaine spray 
THE COMFORT LAB LLC

----------

The Comfort Lab (as PLD) - SOLE SERUM (61867-101) - DELIST

Active Ingredient

Lidocaine Hydrochloride 4%

Purpose
External Analgesic

Use
For temporary relief of minor aches and pains of
muscles and joints.

Warnings
For external use only. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Do not use in large quantities, particularly over raw surfaces or blistered areas. Avoid contact with the eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN.

Directions
Apply 2 pumps to foot where pain is felt. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Acrylates/Dimethicone Copolymer, Alkyl Benzoate, Diazolidinyl Urea, Ethoxydiglycol, Ethylenediaminetetraacetic acid, Disodium EDTA, Ethylhexyl Palmitate, Glyceryl Stearate, Peg 100 Stearate, Isododecane, Behenyl
Methacrylate/t-Butyl Methacrylate Copolymer, Isopropyl Palmitate, Lavandula Angustifolia (Lavender) Oil, Lecithin, Malaleuca Alternifolia {Tea
Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Menthol, Peg-8 Dimethicone, Phenoxyethanol,Benzoic Acid, Ethylhexylglycerin, Glycereth -2 Cocoate, Poloxamer 407, Potassium Cetyl Phosphate, Potassium Sorbate, Propylene Glycol, Sorbic Acid, Water

Other Information
Provides penetrating foot pain relief

15ML BOTTLE ART

sole serum_15 ml box art

SOLE SERUM 
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61867-101
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
EDETIC ACID (UNII: 9G34HU7RV0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ISODODECANE (UNII: A8289P68Y2)  
TERT-BUTYL METHACRYLATE (UNII: F9029V5818)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHOL (UNII: L7T10EIP3A)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61867-101-511 in 1 BOX02/24/201412/31/2023
1NDC:61867-101-1115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:61867-101-521 in 1 BOX02/24/201412/31/2023
2NDC:61867-101-1230 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/24/201412/31/2023
Labeler - THE COMFORT LAB LLC (079250438)

Revised: 4/2024
 
THE COMFORT LAB LLC