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| Product NDC Code | 73423-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Cbd cryotherapy pain relief roll-on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | Global Widget, 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.Active Ingredients Menthol USP 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 • Shake well before use • Adults 18 years & over rub a thin layer into affected areas up to 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Isopropyl Alcohol, Carbomer, Pure CBD Extract, Triethanolamine
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 pain
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.CBD Cryotherapy Pain Relief Roll-On MENTHOL ISOPROPYL ALCOHOL CANNABIDIOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE MENTHOL MENTHOL
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.Principal Display Panel NATURE'S SCRIPT CBD Cryotherapy Pain Relief Roll-On MENTHOL 4% 3 FL OZ (89 mL) label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Distributed by Global Widget, LLC 8419 Sunstate Street, Tampa, FL 33634
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: On eyes or on mucous membranes On wounds, damaged or irritated skin If you are allergic to Menthol or any of the ingredients listed below
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: Store in cool, dry place away from direct sunlight
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 Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Conditions worsen Symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding: Do not use this product. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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: Use only as directed Do not bandage or cover with any type of wrap except clothing Do not use with heating pad or devices, or apply external heat
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding: Do not use this product.
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 Do not use: On eyes or on mucous membranes On wounds, damaged or irritated skin If you are allergic to Menthol or any of the ingredients listed below When using this product: Use only as directed Do not bandage or cover with any type of wrap except clothing Do not use with heating pad or devices, or apply external heat Stop use and ask a doctor if Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Conditions worsen Symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding: Do not use this product. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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