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| Product NDC Code | 81591-001 | ||||||||
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| Drug Name | Micro-aseptic |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 413262 | ||||||||
| Application Number | part333A | ||||||||
| Labeler Name | ASEPTIC CONTROL PRODUCTS, INC. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient PCMX (para-chloro-meta-xylenol) 0.6%
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 ready to use do not dilute wet hands and forearms apply 5 milliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FD&C Blue #1, FD&C Yellow #5
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.Use for hand-washing to decrease bacteria on the skin
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Micro-Aseptic CHLOROXYLENOL CHLOROXYLENOL CHLOROXYLENOL WATER FD&C BLUE NO. 1 ALOE VERA LEAF FD&C YELLOW NO. 5 SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE PROPYLENE GLYCOL ISOPROPYL ALCOHOL DMDM HYDANTOIN PEG-75 LANOLIN LAURAMINE OXIDE SODIUM LAURETH SULFATE EDETATE SODIUM BORIC ACID
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.Micro- Aseptic Antimicrobial Skin Cleanser NDC # 81591-001-02 Manufactured for ASEPTIC CONTROL PRODUCTS, INC 1225 Carnegie Street, Unit 104 Rolling Meadows, IL 60008 Made in the U.S.A. Item #: 1955-16OZ 473 ml (16 FL. OZ.) container label
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
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.Stop use and ask a doctor if irritation and redness develop
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 do not get into eyes of contact occurs, rinse eyes thoroughly with water
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 do not get into eyes of contact occurs, rinse eyes thoroughly with water Stop use and ask a doctor if irritation and redness develop 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