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Product NDC Code | 51151-391 | ||||
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Drug Name | Hempcin advanced topical pain relief cream |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M017 | ||||
Labeler Name | Pedicis Research, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Menthol 5% Purpose Pain Relieving Cream
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 or children 2 years of age and older. Apply externally to affected area not more than 3-4 times daily. • Children under 2 years of age consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil, Cassia Oil, Cetearyl Alcohol, Dimethyl Sulfone (DMSO), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Ilex Paraguariensis (Yerba Mate’) Extract, C13-14 Isoparaffin, Isopropyl Alcohol, Laureth-7, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, 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 minor aches and pain of muscles and joints
Purpose
Information about the drug product’s indications for use.Purpose Pain Relieving Cream
Spl product data elements
Usually a list of ingredients in a drug product.HEMPCIN Advanced Topical Pain Relief Cream MENTHOL WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CANNABIS SATIVA SEED OIL CHINESE CINNAMON OIL CETOSTEARYL ALCOHOL DIMETHYL SULFONE ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE ILEX PARAGUARIENSIS LEAF C13-14 ISOPARAFFIN ISOPROPYL ALCOHOL LAURETH-7 MAGNESIUM SULFATE, UNSPECIFIED FORM TEA TREE OIL PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL STEARIC ACID 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.Package Labeling: 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.Drug Facts:
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 the reach of children: If swallowed get medical help or call 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: Call toll free 1-800-748-6539
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: • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and do not return within a few days • you notice any unusual effects
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 use in large quantities particularly over raw surfaces or blistered areas • do not exceed recommended doses unless recommended by a doctor
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 • Avoid contact with the eyes • Do not apply to wounds or damaged skin • Do not bandage tightly • Cap tube tightly and store at room temperature away from heat When using this product: • do not use in large quantities particularly over raw surfaces or blistered areas • do not exceed recommended doses unless recommended by a doctor Stop use and ask a doctor if: • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and do not return within a few days • you notice any unusual effects Keep out of the reach of children: If swallowed get medical help or call 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