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| Product NDC Code | 76348-660 | ||||
|---|---|---|---|---|---|
| Drug Name | Op 6 menthol warming roll on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | part348 | ||||
| Labeler Name | RENU LABORATORIES, INC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 5 percent
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 adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain. children under 12 years of age: do not use, consulta a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hamamelis Virginiana (Witch Hazel), Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.
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 temporary relief of minor aches and pains of muscles and joints associated with bruises sprains arthritis strains
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.OP 6 MENTHOL WARMING ROLL ON MENTHOL LINALOOL, (+/-)- POLYSORBATE 80 METHYLCELLULOSE (4000 CPS) MENTHOL MENTHOL MAGNESIUM SULFATE, UNSPECIFIED PEPPERMINT OIL WATER WITCH HAZEL MAGNESIUM CHLORIDE PINENE ARNICA MONTANA SODIUM BENZOATE POTASSIUM SORBATE ISOPROPYL ALCOHOL CANNABIDIOL LIMONENE, (+)- TABASCO PEPPER MYRCENE CARYOPHYLLENE CANNABIS SATIVA SEED OIL
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.OP6 WARMING ROLL ON LABEL AND OUTER BOX BOX OP6 WARMING ROLL ON warming OP6 LABEL
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.THERE ARE NO SUBSTANTIVE LABELING CHANGES IN THE SECTION dosage and administration
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Comments? www.HempforLifeWellness.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin do not use with heating pads or other heating devices.
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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me 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