SOLE SERUM- lidocaine spray

SOLE SERUM by

Drug Labeling and Warnings

SOLE SERUM by is a Otc medication manufactured, distributed, or labeled by THE COMFORT LAB LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine Hydrochloride 4%

PURPOSE

Purpose
External Analgesic

INDICATIONS & USAGE

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

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLE SERUM 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61867-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61867-101-51	1 in 1 BOX
1	NDC: 61867-101-11	15 mL in 1 BOTTLE
2	NDC: 61867-101-52	1 in 1 BOX
2	NDC: 61867-101-12	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/24/2014

Labeler - THE COMFORT LAB LLC (079250438)

Registrant - THE COMFORT LAB LLC (079250438)