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Product NDC Code | 62742-4091 | ||||
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Drug Name | Pain relief cream |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 313518 | ||||
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.Contains Gradual Heating Sensation. Adults and Children 12 years of age and older: use no more than 3-4 times daily. Before Activity-Massage onto muscles and joints 10-30 minutes before to warm up. After - Apply cream to sore or injured areas immediately after activity or after showering. Wash hands thoroughly with soap and water after use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acetyl Glucosamine, Butylene Glycol, Capriylic/ Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol,Cyclopentasilaxane, Dimethicone, Dimethyl Sulfone (MSM), Disodium EDTA, Fragrance, Glyceryl Stearate, Imidazolidinyl Uraea, Isopropyl Palmitate, Lecithine, PEG-100 Stearate, Phenoxy ethanol, Potassium Sorbitate, Tocopheryl Acetate, Vanillyl Butyl Ethar, Water, 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 the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, 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.Pain Relief Cream Trolamine Salicylate TROLAMINE SALICYLATE SALICYLIC ACID DISODIUM ACETYL GLUCOSAMINE PHOSPHATE BUTYLENE GLYCOL CETEARETH-2 DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) DIMETHICONE DIMETHYL SULFONE EDETATE DISODIUM GLYCERYL STEARATE CITRATE N-(1,3-BIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA ISOPROPYL PALMITATE LECITHIN, SOYBEAN PEG-100 STEARATE PHENOXYETHANOL VANILLYL BUTYL ETHER WATER XANTHAN GUM TOCOPHEROL 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.Distributed by: Flex Power Inc. Berkeley, CA 94710 Image FlxPower20.jpg Image FlxPower40.jpg
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.Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate.
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.
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.If pain persist more than 7 days or redness or irritation is present or in condition affecting children under 12 years of age, consult a physician immediately.
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: Avoid contact w ith eyes or mucous membranes; if contacts occurs, flush with water for 15 minutes. Do not apply to wounds or damaged skin.
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.
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