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| Product NDC Code | 73647-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Just cbd roll-on cooling |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | Just Brands LLC | ||||
| 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.Menthol ………………………………...…………………………….…. 4%
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 over 21 years Apply a small amount on the affected area. Massage in circular motion until absorbed, let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Caprylic/Capric Triglyceride, Cannabidiol, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Methyl Salicylate, FD&C Blue No. 1 (CI 42090).
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: Aid for temporary local relief of minor pain in muscles and joints.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.JUST CBD ROLL-ON COOLING MENTHOL SORBIC ACID METHYL SALICYLATE CANNABIDIOL MENTHOL MENTHOL WATER GLYCERIN SALICYLIC ACID CARBOMER 940 SODIUM HYDROXIDE CETEARETH-25 BENZYL ALCOHOL ALCOHOL CALENDULA OFFICINALIS FLOWER FD&C BLUE NO. 1 MEDIUM-CHAIN TRIGLYCERIDES JUST CBD ROLL-ON COOLING MENTHOL SORBIC ACID METHYL SALICYLATE CANNABIDIOL MENTHOL MENTHOL WATER GLYCERIN SALICYLIC ACID CARBOMER 940 SODIUM HYDROXIDE CETEARETH-25 BENZYL ALCOHOL ALCOHOL CALENDULA OFFICINALIS FLOWER FD&C BLUE NO. 1 MEDIUM-CHAIN TRIGLYCERIDES
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.JUST CBD ROLL-ON COOLING GEL +1500 COOLING 1500
JUST CBD ROLL-ON COOLING GEL +350 COOLING 350
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.If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C). Cannabidiol (CBD*) use, while taking any medication, or have any medical condition may be harmful. Consult a healthcare professional before use. This product is intended only for use by healthy adults aged 21 years & older.
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.• Avoid contact with the eyes or mucous membranes. • Do not apply to wounds or damaged skin. • Do not apply to the irritated skin or if excessive irritation develops. • Do not bandage tightly. • Do not use with heating pad or device. • 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIF PREGNANT OR BREAST – FEEDING: Ask a health professional before use.
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.• For external use only. • Ask a doctor before use if you have redness over affected area.
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