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| Product NDC Code | 70542-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Maxim fdf |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOAP | ||||
| RxCUI drug identifier | 1941461 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Midlab Incorporated | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Chloroxylenol 0.1%
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 • Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly. • Children under 6 years of age should be supervised when using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (68439-57-6), Glycerin (56-81-5), Cocamidopropyl Hydroxysultaine (68139-30-0), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium Polyitaconate (26099-89-8), Dibromocyanoacetamide (10222-01-2), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4).
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 • Handwash to help decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Maxim FDF chloroxylenol COCAMIDOPROPYL HYDROXYSULTAINE DIBROMOCYANOACETAMIDE PROPANEDIOL BRONOPOL SODIUM C14-16 OLEFIN SULFONATE GLYCERIN SODIUM POLYITACONATE (2800 MW, PHOSPHATE TERMINATED) WATER PROPYLENE GLYCOL CHLOROXYLENOL CHLOROXYLENOL METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE
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.Principal Display Panel
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 a doctor if irritation or rash appears and lasts.
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. Do not use in the eyes. In case of contact, immediately flush eyes with water.
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