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Product NDC Code | 76348-960 | ||||
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Drug Name | Inked science lidocaine 4 percent |
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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 | 1010895 | ||||
Application Number | part348 | ||||
Labeler Name | RENU LABORATORIES, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine HCl 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: adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day Children under 2 years, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol
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: to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches or burns.
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.INKED SCIENCE LIDOCAINE 4 Percent Lidocaine HCL HEXYLENE GLYCOL HIPPOPHAE RHAMNOIDES SEED OIL WATER MEDIUM-CHAIN TRIGLYCERIDES LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS PROPYLENE GLYCOL JOJOBA OIL CETOSTEARYL ALCOHOL ARNICA MONTANA FLOWER CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN STEARIC ACID TOCOPHEROL POLYSORBATE 20 HIPPOPHAE RHAMNOIDES FRUIT OIL GLYCERIN PHENOXYETHANOL SODIUM HYDROXIDE EDETATE SODIUM WHITE WAX
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.PRODUCT LABEL AND PRODUCT BOX INKED SCIENCE BOX LABEL ART INKED SCIENCE
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.INDICATIONS AND USAGE Only a date change due to creation of a CLONE SPL. DOSAGE and ADMINISTRATION Only a date change due to creation of a CLONE SPL
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.Store at 20 - 25° C
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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 return within a few days redness, irritation, swelling, pain or other symptoms begin.
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 or near the eyes do not use in large quantities, particularly over raw surfaces or blistered areas.
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