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Product NDC Code | 62742-4198 | ||||
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Drug Name | Cbd pain relief cream |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part348 | ||||
Labeler Name | Allure Labs Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Trolamine Salicylate 10%
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 over 12 years of age: • Apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 times daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water (Aqua), Coconut Alkanes*, Sorbitan Olivate*, Cetearyl Olivate*, Glycerin*, Dimethyl Sulfone, Glyceryl Stearate*,Cannabidiol (From Hemp Extract), Stearic Acid*, Cetyl Palmitate*, Rosa Moschata Seed Oil*, Cetearyl Alcohol, Ceteareth-20, Sorbitan Palmitate*, Tocopherol, Vanillyl Butyl Ether, Coco-Caprylate/Caprate*, Caprylhydroxamic acid*, Glyceryl Caprylate*, 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 temporary relief of minor aches and pains of the muscles and joints (such as arthritis, backache, sprains and bruises).
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 Pain Relief Cream Trolamine Salicylate CAPRYLHYDROXAMIC ACID COCONUT ALKANES CANNABIDIOL ROSA MOSCHATA SEED OIL VANILLYL BUTYL ETHER TROLAMINE SALICYLATE SALICYLIC ACID WATER GLYCERYL MONOSTEARATE TOCOPHEROL COCO-CAPRYLATE/CAPRATE GLYCERYL CAPRYLATE SORBITAN OLIVATE GLYCERIN DIMETHYL SULFONE CETEARYL OLIVATE CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER SORBITAN MONOPALMITATE XANTHAN GUM STEARIC ACID CETYL PALMITATE
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.Manufactured for DermaQuest®, Inc. Hayward CA-94544 Made In USA dermaquestinc.com IMGCBDPRC
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.Children 12 years or younger: • Ask a doctor
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 at room temperature ALLERGY ALERT - If prone to allergic reaction from aspirin orsalicylates, consult a doctor before use.
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 symptoms persists for more tham 7 days or clear up and occurs again within few days. Redness is present irritaiotn develops
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 tightly or use with a heating pad avoid contact eith eyes or mucus membranes do not apply to wounds or damaged skin
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breat 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.Warnings: For external use only Keep out of reach of children
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