NDC 62168-0805 Icy Hot Medicated, Advanced Relief

Menthol

NDC Product Code 62168-0805

NDC 62168-0805-2

Package Description: 300 POUCH in 1 BOX > 4 PATCH in 1 POUCH (62168-0805-1)

NDC 62168-0805-3

Package Description: 5 PATCH in 1 POUCH

NDC Product Information

Icy Hot Medicated, Advanced Relief with NDC 62168-0805 is a a human over the counter drug product labeled by Lead Chemical Co. Ltd.. The generic name of Icy Hot Medicated, Advanced Relief is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Lead Chemical Co. Ltd.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Icy Hot Medicated, Advanced Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL, UNSPECIFIED FORM 210 mg/1

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.

  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • NONOXYNOL-30 (UNII: JJX07DG188)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • TALC (UNII: 7SEV7J4R1U)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • NONOXYNOL-30 (UNII: JJX07DG188)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • TALC (UNII: 7SEV7J4R1U)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • NONOXYNOL-30 (UNII: JJX07DG188)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • TALC (UNII: 7SEV7J4R1U)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Lead Chemical Co. Ltd.
Labeler Code: 62168
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-01-2012 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: 12-31-2019 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Icy Hot Medicated, Advanced Relief 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

Active Ingredient

Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL PatchesMenthol 5%Icy Hot Advanced Relief PatchesMenthol 7.5%

Purpose

Topical analgesic

Uses

  • Icy Hot Arm, Neck and Leg Patchestemporarily relieves minor aches and pains associated with: •arthritis •simple backache •bursitis •tendonitis •muscle strains •sprains •bruises •crampsIcy Hot Back Patches; and Icy Hot XL Patchestemporarily relieves minor pain associated with: •arthritis •simple backache •bursitis •tendonitis •muscle strains •sprains •bruises •crampsIcy Hot Advanced Relief Patchestemporarily relieves minor pain associated with: •arthritis •simple backache •muscle strains •sprains •bruises •cramps

Warnings

For external use only

When Using This Product

  • Icy Hot Arm, Neck and Leg Patches •use only as directed •do not bandage tightly or use with a heating pad •avoid contact with eyes and mucous membranes •do not apply to wounds or damaged, broken or irritated skinIcy Hot Back Patches; and Icy Hot XL Patches •use only as directed. Read and follow all directions and warnings on this label. •rare cases of serious burns have been reported with products of this type •do not bandage tightly or apply local heat (such as heating pads) to the area of use •avoid contact with eyes and mucous membranes •do not apply to wounds or damaged, broken or irritated skin •do not use at the same time as other topical analgesicsIcy Hot Advanced Relief Patches •use only as directed •do not bandage tightly or use with a heating pad •avoid contact with eyes and mucous membranes •do not apply to wounds or damaged, broken or irritated skin •do not use at the same time as other topical analgesics

Stop Use And Ask A Doctor If

  • Icy Hot Arm, Neck and Leg Patches; Icy Hot Advanced Relief Patches •condition worsens •redness is present •irritation develops •symptoms persist for more than 7 days or clear up and occur again within a few daysIcy Hot Back Patches and Icy Hot XL Patches •condition worsens •redness is present •irritation develops •symptoms persist for more than 7 days or clear up and occur again within a few days •you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Icy Hot Arm, Neck and Leg Patchesadults and children over 12 years: •remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle •carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area •once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area •wear one Icy Hot Patch up to 8 hours •repeat as necessary, but no more than 3 times dailychildren 12 years or younger: ask a doctorIcy Hot Back Patches; and Icy Hot XL Patchesadults and children over 12 years: •remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle •carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area •once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area •wear one Icy Hot Patch for up to 8 hours •repeat as necessary, but no more than 3 times dailychildren 12 years or younger: ask a doctorIcy Hot Advanced Relief Patchesadults and children over 12 years: •gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain. •remove remaining film backing from both sides and finish applying to skin •use 1 patch for up to 12 hours, once a daychildren 12 years or younger: ask a doctor

Inactive Ingredients

Icy Hot Arm, Neck and Leg Patchesaluminum hydroxide, carmellose sodium, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water Icy Hot Back Patches; and Icy Hot XL Patchesaluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, waterIcy Hot Advanced Relief Patchesglyceryl hydrogenated rosinate, hydrated silica, mineral oil, PEG-400, polyisobutene, styrene/isoprene copolymer

* Please review the disclaimer below.