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| Product NDC Code | 80513-813 | ||||
|---|---|---|---|---|---|
| Drug Name | Puregen labs maximum strength lidocaine |
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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 | 1366789 | ||||
| Application Number | M015 | ||||
| Labeler Name | Advanced Rx LLC | ||||
| 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 5.00 % Purpose Anorectal (hemorrhoidal)
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: When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor. Apply externally to the affected area up to 6 times daily or after each bowel movement.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Ethylhexylglycerin, Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6
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 Helps relieve the local itching and discomfort in the perianal area For the temporary relief of pain, irritation” or burning.
Purpose
Information about the drug product’s indications for use.Purpose Anorectal (hemorrhoidal)
Spl product data elements
Usually a list of ingredients in a drug product.PUREGEN LABS Maximum Strength Lidocaine LIDOCAINE ALLANTOIN ALOE VERA LEAF WATER BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DIMETHYL ISOSORBIDE ETHYLHEXYLGLYCERIN ETHYLHEXYL STEARATE PHENOXYETHANOL PROPYLENE GLYCOL EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE TRIDECETH-6 LIDOCAINE LIDOCAINE
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.Package Labeling: Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information: Protect the product in this container from excessive heat and direct sun.
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 exceed the recommended daily dosage unless directed by a doctor. put this product into the rectum by using fingers or any mechanical device or applicator.
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? call toll-free 1-800-630-8895
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 If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Allergy alert Certain persons can develop allergic reactions to ingredients in this product.
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 If the condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-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 Do not exceed the recommended daily dosage unless directed by a doctor. put this product into the rectum by using fingers or any mechanical device or applicator. When using this product If the condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Allergy alert Certain persons can develop allergic reactions to ingredients in this product. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use
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