NDC 61867-101 Sole Serum

NDC Product Code 61867-101

NDC 61867-101-51

Package Description: 1 BOTTLE in 1 BOX > 15 mL in 1 BOTTLE (61867-101-11)

NDC 61867-101-52

Package Description: 1 BOTTLE in 1 BOX > 30 mL in 1 BOTTLE (61867-101-12)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Sole Serum with NDC 61867-101 is a product labeled by The Comfort Lab Llc. The product's dosage form is and is administered via form.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Comfort Lab Llc
Labeler Code: 61867
Start Marketing Date: 02-24-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sole Serum Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active IngredientLidocaine Hydrochloride 4%

Otc - Purpose

PurposeExternal Analgesic

Indications & Usage

UseFor temporary relief of minor aches and pains ofmuscles and joints.

Warnings

WarningsFor 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

KEEP OUT OF REACH OF CHILDREN.

Dosage & Administration

DirectionsApply 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 IngredientsAcrylates/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 {TeaTree) 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 InformationProvides penetrating foot pain relief

* Please review the disclaimer below.