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| Product NDC Code | 72042-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pain relief |
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| Type | Brand | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 1595624 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | HUMN Pharmaceuticals Inc | ||||||
| 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 Lidocaine Hydrochloride 4.0% (w/w) Menthol 1.0% (w/w)
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 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/Acrylamide Copolymer, Allantoin, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.
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 Temporary relief of: • pain • itching associated with: ▪ minor burns ▪ sunburn ▪ minor cuts ▪ scrapes ▪ insect bites ▪ minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Anesthetic Analgesic, anesthetic, and antipruritic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief Lidocaine, Menthol CETETH-20 ALCOHOL ALUMINUM DICETYL PHOSPHATE GLYCERIN MINERAL OIL PEG-6 STEARATE PEG-100 STEARATE POLYACRYLAMIDE (10000 MW) STEARETH-2 STEARETH-20 CETETH-10 PHOSPHATE PEG-120 GLYCERYL STEARATE IODOPROPYNYL BUTYLCARBAMATE ISOPROPYL MYRISTATE LAURETH-7 LECITHIN, SOYBEAN PHENOXYETHANOL DIMETHICONE 100 POLYSORBATE 85 WATER CAPRYLYL GLYCOL CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE MENTHOL MENTHOL C13-14 ISOPARAFFIN ACRYLAMIDE CETYL ALCOHOL YELLOW WAX BUTYLENE GLYCOL ALKYL (C12-15) BENZOATE LIDOCAINE HYDROCHLORIDE ANHYDROUS LIDOCAINE ALLANTOIN .ALPHA.-LIPOIC ACID STEARETH-21
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.TPR20 Pain Relief Label TPR Pain Relief Label
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 child is under 2 years of age, and use only as directed
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 • in large quantities • over large areas of the body • over raw surfaces • over blistered areas
Pain Relief: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other information • do not use if seal is broken • store at 60-85° F
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-335-3596 Monday to Friday 8 am to 6 pm EST .
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 • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days • you experience: pain, swelling, or blistering
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 with eyes; if this happens, rinse thoroughly with water
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.
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