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Product NDC Code | 84023-401 | ||||
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Drug Name | Hemorrhoid ointments |
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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 | PASTE | ||||
Application Number | M017 | ||||
Labeler Name | Shenzhen Yangan Technology Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine 5%
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.Children under 12 years of age consult your pediatrician. Adults: apply to the affected area up to 3 times daily. Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use. To use dispensing cap, attach it to tube, lubricate well. then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aloe barbadebsis leaf juice (Aloe vera) Water Lecithin (Soybean) Carbomer Menthol Triethanolamine
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.Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burnina, itching). Temporarily reduces the sweling associated with irritated hemorrhoidal tissue and other anorectal disorders.
Purpose
Information about the drug product’s indications for use.Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.HEMORRHOID OINTMENTS Lidocaine LECITHIN, SOYBEAN TROLAMINE WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE MENTHOL LIDOCAINE LIDOCAINE ALOE
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.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.Hemorrhoid Ointment
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.lf pregnant or breast-feeding, ask a health care professional before use
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. lf swallowed, seek medical help or contact a Poison Contro 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.Condition worsens or does not improve within seven (7) days. Bleeding occurs. Introduction of applicator into the rectum causes additional pain.
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.Do not exceed recommended daily dosage unless directed by a doctor. Ask a doctor before use if you have: Allergies to any of the components of this product. Difficulty in urination due to enlargement of the prostate gland. Diabetes: Heart Disease : High Blood Pressure Thyroid Disease. Presently taking a prescription for high blood pressure or depression.
Storage and handling
Information about safe storage and handling of the drug product.Store at 59* to 77*F to avoid melting
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.For externaand/or intrarectal use only
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