SOLE SERUM

Manufacturer: THE COMFORT LAB LLC
Effective date: 2014-06-28
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:35:51

Label at a glance#

ProductSOLE SERUM

Active ingredientLIDOCAINE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine Hydrochloride 4%

OTC - PURPOSE SECTION

Purpose
External Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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 SAFETY INFORMATION

Other Information
Provides penetrating foot pain relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15ML BOTTLE ART

sole serum_15 ml box art

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61867-101-51	2024-04-01	C162847	48780-1	9855e2a2-4d5b-60a7-e053-dbdaa90a05bd	3d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-52	2024-04-01	C162847	48780-1	9855e2a2-4d5b-60a7-e053-dbdaa90a05bd	3d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-51	2019-11-27	C162847	48780-1	9855e2a2-4d5b-60a7-e053-dbdaa90a05bd	3d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-52	2019-11-27	C162847	48780-1	9855e2a2-4d5b-60a7-e053-dbdaa90a05bd	3d855db4-b10f-474b-88fc-fdade8a8226e

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	3
LIDOCAINE	ACTIVE MOIETY	98PI200987	3
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	3
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	3
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	3
Ethylhexyl Palmitate	INACTIVE INGREDIENT	2865993309	3
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	3
GLYCERETH-2 COCOATE	INACTIVE INGREDIENT	JWM00VS7HC	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
ISODODECANE	INACTIVE INGREDIENT	A8289P68Y2	3
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	3
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	3
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	3
PEG-8 DIMETHICONE	INACTIVE INGREDIENT	GIA7T764OD	3
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	3
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	3
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	3
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	3
TERT-BUTYL METHACRYLATE	INACTIVE INGREDIENT	F9029V5818	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

SOLE SERUM
LIDOCAINE
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61867-101	61867-101-11, 61867-101-51, 61867-101-12, 61867-101-52

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIDOCAINE	98PI200987	ACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
EDETIC ACID	9G34HU7RV0	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
Ethylhexyl Palmitate	2865993309	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
ISODODECANE	A8289P68Y2	IACT
TERT-BUTYL METHACRYLATE	F9029V5818	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
TEA TREE OIL	VIF565UC2G	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
MENTHOL	L7T10EIP3A	IACT
PEG-8 DIMETHICONE	GIA7T764OD	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLYCERETH-2 COCOATE	JWM00VS7HC	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POTASSIUM CETYL PHOSPHATE	03KCY6P7UT	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBIC ACID	X045WJ989B	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 348 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL, SPRAY / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SOLUTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / TOPICAL		28 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHER	DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	LOTION / TOPICAL		714 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / ORAL		100 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CONCENTRATE / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 23 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / PERIODONTAL	155 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / ORAL	15 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
150ee024-f552-b982-e063-6394a90a3f75			3d855db4-b10f-474b-88fc-fdade8a8226e	2024-04-01	Warnings	Exact identifier spl set id: 3d855db4-b10f-474b-88fc-fdade8a8226e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.