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| Product NDC Code | 63742-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Numb520 |
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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 | ||||
| RxCUI drug identifier | 2168528 | ||||
| Application Number | M015 | ||||
| Labeler Name | Clinical Resolution Laboratory, 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 HCL 5% Phenylephrine HCL, 0.25% Purpose Local Anesthetic Vasoconstrictor
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 clean the affected area. sensitivity and possible allergy tests advised prior to use. Spray spraingly 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, Arginine, 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, discomfort, and pain associated with anorectal disorders 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.Numb520 LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE ALLANTOIN ARGININE BENZYL ALCOHOL EDETATE DISODIUM ANHYDROUS DIETHYLENE GLYCOL MONOETHYL ETHER PHENOXYETHANOL POLYSORBATE 20 WATER SODIUM BENZOATE SODIUM SULFITE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
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 keep away from direct sunlight or heat. store in room temperature (59-86°F / 15-30°C).
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 this product if pregnant or breastfeeding, ask a health professional before use. Tamper Evident "Do not use this product" if safety 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 reach of children.
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 the symptom being treated does not subside, or 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 this product do not exceed the recommended daily usage. certain persons can develop allergic reactions to ingredients in this product. do not put this product into the rectum by using fingers or any medical device or applicator. if swallowed, call your Poison Control Center at 1(800) 222-1222. if condition worsens or does not improve within 7 days, consult a doctor.
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. avoid contact with the eyes. keep out of reach of children. Do not use this product if pregnant or breastfeeding, ask a health professional before use. Tamper Evident "Do not use this product" if safety 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. When using this product do not exceed the recommended daily usage. certain persons can develop allergic reactions to ingredients in this product. do not put this product into the rectum by using fingers or any medical device or applicator. if swallowed, call your Poison Control Center at 1(800) 222-1222. if condition worsens or does not improve within 7 days, consult a doctor. Stop use and ask a doctor if the symptom being treated does not subside, or redness, irritation, swelling, pain, or other symptoms develop or increase.
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