Skip to Content

SOLE SERUM

Medically reviewed on June 28, 2018

Dosage form: spray
Ingredients: LIDOCAINE 4g in 100mL
Labeler: THE COMFORT LAB LLC
NDC Code: 61867-101

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.

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

SOLE SERUM 
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61867-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
ALKYL (C12-15) BENZOATE 
DIAZOLIDINYL UREA 
DIETHYLENE GLYCOL MONOETHYL ETHER 
EDETIC ACID 
EDETATE DISODIUM 
Ethylhexyl Palmitate 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
ISODODECANE 
TERT-BUTYL METHACRYLATE 
ISOPROPYL PALMITATE 
LAVENDER OIL 
LECITHIN, SOYBEAN 
TEA TREE OIL 
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 
Packaging
#Item CodePackage Description
1NDC:61867-101-511 BOTTLE in 1 BOX
1NDC:61867-101-1115 mL in 1 BOTTLE
2NDC:61867-101-521 BOTTLE in 1 BOX
2NDC:61867-101-1230 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/24/2014
Labeler - THE COMFORT LAB LLC (079250438)
Registrant - THE COMFORT LAB LLC (079250438)

 
THE COMFORT LAB LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide