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Product NDC Code | 70742-286 | ||||
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Drug Name | Body action products butt eze benzocaine |
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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 | GEL | ||||
Application Number | M015 | ||||
Labeler Name | PRODUCT MAX GROUP INC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzocaine 5% Purpose Anorectal (Hemorrhoidal) Gel
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 practial, 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 to the affected area up to 6 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Cannabis Sativa (Hemp) Seed Oil, Hydroxyethylcellulose, Methylparaben, PEG-8, Polysorbate 20, Propylene Glycol, Propylparaben, 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 For temporary relief of pain or soreness in the perianal area.
Purpose
Information about the drug product’s indications for use.Purpose Anorectal (Hemorrhoidal) Gel
Spl product data elements
Usually a list of ingredients in a drug product.BODY ACTION PRODUCTS Butt Eze Benzocaine BENZOCAINE CANNABIS SATIVA SEED OIL HYDROXYETHYL CELLULOSE, UNSPECIFIED METHYLPARABEN POLYETHYLENE GLYCOL 400 POLYSORBATE 20 PROPYLENE GLYCOL PROPYLPARABEN WATER BENZOCAINE BENZOCAINE
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.Package Labeling: 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.Drug Facts
Other Information Do not use if safety seal is broken or missing.
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.
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. Avoid contact with the eyes. Certain persons can develop allergic reactions from ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. 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