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Flexible pain relief gel - Prescription Drug Labeling

Product NDC Code 73096-027
Drug Name

Flexible pain relief gel

Type Brand
Active Ingredients
Menthol, unspecified form 1928 mg/96.4g
Route TOPICAL
Dosage Form GEL
Application Number part348
Labeler Name Harmony Product LLC
Packages
Package NDC Code Description
73096-027-02 1 bottle, dispensing in 1 carton (73096-027-02) > 96.4 g in 1 bottle, dispensing (73096-027-01)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Menthol 2% Active ingredient Menthol 2% Active ingredient Menthol 2.5% Active ingredient Menthol 2% Active ingredient Menthol 2.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
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

Spl product data elements

Usually a list of ingredients in a drug product.
Flexible Pain Relief Gel Extra Strength Pain Relief Gel Extra Strength POLYSORBATE 20 EUCALYPTUS GLOBULUS LEAF MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ARNICA MONTANA FLOWER CETYL ALCOHOL COMFREY LEAF SAFFLOWER OIL WATER OLIVE OIL EDETATE SODIUM EDETIC ACID ALOE VERA LEAF CANNABIS SATIVA SEED OIL PHENOXYETHANOL TROLAMINE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) DIMETHYL SULFONE ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE POTASSIUM CHLORIDE GLYCERIN HEMP SALIX ALBA BARK Flexible Pain Relief Roll-on Extra Strength Pain Relief Roll-on Extra Strength XANTHAN GUM POLYSORBATE 20 MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ARNICA MONTANA FLOWER COMFREY LEAF WATER ALOE VERA LEAF CANNABIS SATIVA SEED OIL PHENOXYETHANOL DIMETHYL SULFONE ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE POTASSIUM CHLORIDE GLYCERIN HEMP SALIX ALBA BARK EUCALYPTUS GLOBULUS LEAF Flexible Pain Relief Roll-on Pain Relief Roll-on POLYSORBATE 20 MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ARNICA MONTANA FLOWER COMFREY LEAF WATER ALOE VERA LEAF CANNABIS SATIVA SEED OIL PHENOXYETHANOL DIMETHYL SULFONE ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE POTASSIUM CHLORIDE GLYCERIN HEMP SALIX ALBA BARK EUCALYPTUS GLOBULUS LEAF XANTHAN GUM Flexible Pain Relief Gel Pain Relief Gel ARNICA MONTANA FLOWER CETYL ALCOHOL COMFREY LEAF SAFFLOWER OIL WATER OLIVE OIL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM EUCALYPTUS GLOBULUS LEAF EDETATE SODIUM EDETIC ACID ALOE VERA LEAF CANNABIS SATIVA SEED OIL PHENOXYETHANOL TROLAMINE POLYSORBATE 20 CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) DIMETHYL SULFONE ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE POTASSIUM CHLORIDE GLYCERIN HEMP SALIX ALBA BARK Flexible Pain Relief Pain Relief Lotion MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM POLYSORBATE 20 EUCALYPTUS GLOBULUS LEAF ARNICA MONTANA FLOWER CETYL ALCOHOL COMFREY LEAF SAFFLOWER OIL WATER OLIVE OIL EDETATE SODIUM EDETIC ACID ALOE VERA LEAF CANNABIS SATIVA SEED OIL PHENOXYETHANOL TROLAMINE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) DIMETHYL SULFONE ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE POTASSIUM CHLORIDE GLYCERIN HEMP SALIX ALBA BARK

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
For NDC 73096-026-01 Flexible Pain Relief For NDC 73096-026-01 Flexible Pain Relief 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 Active ingredient Menthol 2% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2%....................................................Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains 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 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: For external use only For NDC 73096-027-01 Flexible Pain Relief Gel For NDC 73096-027-01 Flexible Pain Relief Gel 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 Active ingredient Menthol 2% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2%....................................................Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains 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 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 For NDC 73096-027-02 Warnings: For external use only For NDC 73096-028-01 Flexible Pain Relief Extra Strength Gel For NDC 73096-028-01 Flexible Pain Relief Extra Strength Gel 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 Active ingredient Menthol 2.5% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2.5%....................................................Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains 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 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 For NDC 73096-028-02 Warnings: For external use only For NDC 73096-029-01 Flexible Pain Relief Roll-on For NDC 73096-029-01 Flexible Pain Relief Roll-on 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 Active ingredient Menthol 2% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2%....................................................Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains 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 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 For NDC 73096-029-02 Warnings: For external use only For NDC 73096-030-01 Flexible Pain Relief Extra Strength Roll-on For NDC 73096-030-01 Flexible Pain Relief Extra Strength Roll-on 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 Active ingredient Menthol 2.5% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2.5%....................................................Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains 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 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 For NDC 73096-030-02 Warnings: For external use only

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains 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

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API