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| Product NDC Code | 83365-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocaine |
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| Type | Brand | ||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | part348 | ||||
| Labeler Name | Sichuan Gumo Brand Management Co.,Ltd | ||||
| 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 Ingredient Lidocaine Hcl 5% Phenylephrine Hcl 0.25%
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 Cleanse the affected area. Sensitivity and possible allergy tests advised prior to use Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs . You may reapply to continue numbing effect. apply to the affected area up to 4 times daily. children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Allantoin, Arginline, Benzyl Alcohol, Disodium EDTA , Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite
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 local and anorectal itching , discomfortand pain associated with anorectal disorder or anorectal inflammation.
Purpose
Information about the drug product’s indications for use.Purpose Local Anesthetic Vasoconstrictor
Spl product data elements
Usually a list of ingredients in a drug product.LIDOCAINE LIDOCAINE spray PHENOXYETHANOL POLYSORBATE 20 LIDOCAINE LIDOCAINE SODIUM BENZOATE BENZYL ALCOHOL EDETATE DISODIUM ANHYDROUS WATER SODIUM SULFITE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DIETHYLENE GLYCOL MONOETHYL ETHER ARGININE ALLANTOIN
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.83365-001-01
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 Do not use this product if : pregnant or breastfeeding, ask a health professional before use. tamper-evident " Do not se this product if seal is broken or missing. you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
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 Keep Out Of Reach Of Children If Swallowed .Get Medical Help Or Contact A Poison Control Center Right Away
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 Stop use and ask a doctor if The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.
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 When using this product do not exceed the recommended the daily usage. certain persons can develop allergic reactions to ingredients in this product. do nut put this product into the rectum by using finger or any medical device or applicator. If swallowed, call your Poison Control Center immediately. If condition worsens or does not improve within 7 days, consult a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other Information Keep away from direct sunlight or heat. store in room temperature (59-86F/15-30C)
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 Do not use this product if : pregnant or breastfeeding, ask a health professional before use. tamper-evident " Do not se this product if seal is broken or missing. you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
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