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Product NDC Code | 54859-513 | ||||
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Drug Name | Dologesic roll-on |
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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 | LIQUID | ||||
RxCUI drug identifier | 1987647 | ||||
Application Number | part348 | ||||
Labeler Name | Llorens Pharmaceutical International Division, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine HCL, USP 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 over 12 years of age Apply generously to the affected area as needed every 6-8 hours, not to exceed 3 application in a 24 hour period. Not for use in children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham 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.Use Temporarily relieves minor pains
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.Dologesic Roll-On Lidocaine Hcl LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS CAMPHOR (SYNTHETIC) GLYCERIN ISOPROPYL ALCOHOL MENTHOL METHYLPARABEN PROPYLPARABEN WATER XANTHAN GUM
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.DologesicRollOn
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 Llorens Pharmaceutical International Division, Inc. Miami Fl 33147
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor 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 Do not use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this label. do not allow contact with eyes do not bandage or apply local heat (such as heating pads) to the area of use. Stop use and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
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