NDC 73096-028 Flexible Pain Relief Gel Extra Strength

Pain Relief Gel Extra Strength

NDC Product Code 73096-028

NDC Code: 73096-028

Proprietary Name: Flexible Pain Relief Gel Extra Strength What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Pain Relief Gel Extra Strength What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73096 - Harmony Product Llc
    • 73096-028 - Flexible Pain Relief Gel Extra Strength

NDC 73096-028-02

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON > 96.4 g in 1 BOTTLE, DISPENSING (73096-028-01)

NDC Product Information

Flexible Pain Relief Gel Extra Strength with NDC 73096-028 is a a human over the counter drug product labeled by Harmony Product Llc. The generic name of Flexible Pain Relief Gel Extra Strength is pain relief gel extra strength. The product's dosage form is gel and is administered via topical form.

Labeler Name: Harmony Product Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Flexible Pain Relief Gel Extra Strength 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 2410 mg/96.4g

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.

  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • COMFREY LEAF (UNII: DG4F8T839X)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • WATER (UNII: 059QF0KO0R)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HEMP (UNII: TD1MUT01Q7)
  • SALIX ALBA BARK (UNII: 205MXS71H7)

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: Harmony Product Llc
Labeler Code: 73096
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 07-10-2019 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: 12-31-2020 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.

Flexible Pain Relief Gel Extra Strength 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

Recent Major Changes

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprainsDirections for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Inactive Ingredient

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Otc - Active Ingredient

Active ingredient Menthol 2%

Active ingredient Menthol 2%

Active ingredient Menthol 2.5%

Active ingredient Menthol 2%

Active ingredient Menthol 2.5%

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Purpose

Purpose Menthol 2%....................................................Topical Analgesic

Purpose Menthol 2%....................................................Topical Analgesic

Purpose Menthol 2.5%....................................................Topical Analgesic

Purpose Menthol 2%....................................................Topical Analgesic

Purpose Menthol 2.5%....................................................Topical Analgesic

Indications & Usage

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Dosage & Administration

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Otc - Ask Doctor

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Warnings

Warnings: For external use only

Warnings: For external use only

Warnings: For external use only

Warnings: For external use only

Warnings: For external use only

* Please review the disclaimer below.

Previous Code
73096-027
Next Code
73096-029