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| Product NDC Code | 0536-1339 | ||||
|---|---|---|---|---|---|
| Drug Name | Anorectal lidocaine cream |
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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 | part346 | ||||
| Labeler Name | RUGBY LABORATORIES | ||||
| 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% w/w
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 • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying . • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. • Children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E
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 pain, itching, and burning associated with hemorrhoids and other anorectal disorders.
Purpose
Information about the drug product’s indications for use.Purpose Local anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.ANORECTAL Lidocaine Cream Lidocaine LIDOCAINE LIDOCAINE BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HYDROGENATED SOYBEAN LECITHIN ISOPROPYL MYRISTATE POLYSORBATE 80 PROPYLENE GLYCOL WATER TROLAMINE .ALPHA.-TOCOPHEROL
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.Packaging Rugby-1339
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.Compare to the active ingredient in Recticare ® Anorectal Cream†† • For the temporary relief of anorectal itching & discomfort associated with hemorrhoids • Helps relieve pain, soreness & burning • Highest OTC lidocaine strength available + 10 FINGER COTS* READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. TAMPER EVIDENT: DO NOT USE IF THE TUBE IS DAMAGED OR TAMPERED WITH. Close cap tightly after each use. ††This product is not manufactured or distributed by Ferndale Healthcare ® , Inc., a subsidiary of Ferndale Pharma Group, Inc., owner of the registered trademark RectiCare ® .
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? 1-800-645-2158
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature (20-25°C) (68-77°F). Avoid excessive heat and cold. Protect from sunlight.
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 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 • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase • symptoms clear up and return within a few days If pregnant or breast feeding , 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