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Product NDC Code | 69550-324 | ||||
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Drug Name | Assist ii anorectal (hemorrhoidal) |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 360347 | ||||
Application Number | part346 | ||||
Labeler Name | Texas Electrolysis Supply | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzocaine (20.0%)
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 up to 3 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 Ethanol, Benzyl Alcohol, Isopropyl Alcohol, Purified Water, Laureth 4, Tert-Butyl Alcohol, Brucine Sulfate.
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.Indications • For the temporary relief of local discomfort associated with anorectal inflammation. • For the temporary relief of pain, soreness, or burning.
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Assist II Anorectal (Hemorrhoidal) Benzocaine BENZOCAINE BENZOCAINE WATER TERT-BUTYL ALCOHOL BRUCINE SULFATE ALCOHOL BENZYL ALCOHOL ISOPROPYL ALCOHOL LAURETH-4
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.Assist II Anorectal (Hemorrhoidal) Lotion Assist
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information External Anesthetic
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments Texas Electrolysis Supply 16627 Sealark Rd. Houston, Texas 77062 Toll-Free: 1-800-626-6025 Internet: www.texaselectrolysisstore.com
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 • If condition worsens or does not improve within 7 days, consult a doctor. • Do not exceed the recommended daily dosage unless directed by a doctor. • In case of bleeding, consult a doctor promptly. • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Certain persons can develop allergic reactions to ingredients in this product. • If the symptom, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
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