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| Product NDC Code | 72559-034 | ||||
|---|---|---|---|---|---|
| Drug Name | Curist 5% 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 | M015 | ||||
| Labeler Name | Little Pharma, 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 ingredient Lidocaine 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 Adults: • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Apply externally 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 Alcohol Denat., Aloe Barbadensis Leaf Extract, Benzophenone-4, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tocopheryl Acetate, Water
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 temporarily shrinks hemorrhoidal tissue ■ temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders ■ for the temporary relief of pain ■ for the temporary relief of local itching and discomfort in the perianal area
Purpose
Information about the drug product’s indications for use.Purpose Anorectal (hemorrhoidal) spray
Spl product data elements
Usually a list of ingredients in a drug product.Curist 5% Lidocaine Lidocaine 5% LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WATER SODIUM CITRATE DEHYDRATED ALCOHOL BENZOPHENONE-4 EDETATE DISODIUM ETHYLHEXYLGLYCERIN POLYSORBATE 20 .ALPHA.-TOCOPHEROL ACETATE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ALOE BARBADENSIS LEAF JUICE POWDER PHENOXYETHANOL PROPYLENE GLYCOL
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.curist Lidocaine Spray 5% Spray Anorectal (Hemorrhoidal) Spray Temporary Relief of Pain, Itching, and Burning Numbing Spray Net Wt. 6 fl oz (177 ml) lidocaine spray
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.Distributed by: Little Pharma, Inc. | New York, NY 10023 Made in USA With Globally Sourced Ingredients
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 1-844-243-1241 or email [email protected]
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 rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product sumptom 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 this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding , 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 Flamable, Do not use while smoking or near heat ot flame When using this product ■ avoid spraying in eyes ■ do not puncture or incinerate ■ do not store at temperature above 86 F ■ do not exceed recommended daily dosage unless directed by doctor ■ do not put this product into rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of prostate gland Ask a doctor or pharmacist before use if you are ■ presently taking a prescription drug for high blood pressure or depression Stop use and ask doctor if ■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222). When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product sumptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breastfeeding , ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
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