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| Product NDC Code | 69315-301 | ||||
|---|---|---|---|---|---|
| Drug Name | Rectasmoothe |
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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 | Leading Pharma, 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 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 thouroughly. 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 six times a day. Children under 12 years of age: Consult a doctor To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax
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 relive 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.RectaSmoothe Lidocaine 5% LIDOCAINE LIDOCAINE WATER CETYL ALCOHOL GLYCERYL STEARATE SE METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN PETROLATUM WHITE WAX
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.Lidocaine 5% Label Carton
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask 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 suside or if redness, irritation swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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 the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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 the eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any other mechanical device or applicator Stop use and ask 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 suside or if redness, irritation swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at 25 ° C (77 ° F); excursions permitted to 15 ° -30 ° C (59 ° -86 ° F) [see USP Controlled Room Temperature].
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 the eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any other mechanical device or applicator Stop use and ask 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 suside or if redness, irritation swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days Keep out of the 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