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| Product NDC Code | 64536-8760 | ||||
|---|---|---|---|---|---|
| Drug Name | Soft care defend antibacterial handwash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 413257 | ||||
| Application Number | part333A | ||||
| Labeler Name | Diversey, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Chloroxylenol 1.0%
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 Wet hands and forearms. Apply 0.4 mL or 1.0 mL of soap to hands. Lather hands and forearms for at least 30 seconds, rinse thoroughly with potable water. Supervise children when they use this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Ammonium Lauryl Sulfate, Alcohol Denat, Sodium Lauryl Ether Sulfate, Propylene Glycol, Hydroxyethyl cellulose, Tetrasodium EDTA, Isopropyl Alcohol
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 handwashing to decrease bacteria on the skin. For occasional use.
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.Soft Care Defend Antibacterial Handwash Chloroxylenol SODIUM LAURETH-3 SULFATE WATER ALCOHOL PROPYLENE GLYCOL AMMONIUM LAURYL SULFATE HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) ISOPROPYL ALCOHOL EDETATE SODIUM CHLOROXYLENOL CHLOROXYLENOL
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.NDC 64536-8760-2 DIN 02449420 Diversey SoftCare Defend Antibacterial Handwash Chloroxylenol Liquid For comercial use U NSF Nonfood Compounds E2 (L) Exp. Net Contents 3.78 L/1 U.S. Gal. SKU: 100920027 container label container label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions Wet hands and forearms. Apply 0.4 mLor 1.0 mL of soap to hands. Lather hands and forearmsfor at least 30 seconds, rinse thoroughly with potable water. Supervise children when they use this product.
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.Do not use in the eyes.
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. Do not use if you are allergic to any ingredients
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? 1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time www.diversey.com
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. If condition persists for more than 72 hours consult a doctor.
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 the eyes. In case of eye contact, immediately flush with water.
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.Other information EMERGENCY PHONE: 1-800-851-7145 See SDS MS0301547 FOR COMMERCIAL USE. See container for Lot Code and Expiry Date. Store in a cool dry place.
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 Flammable. Keep away from fire or flame. For external use only. Do not ingest Do not use in the eyes. When using this product do not get into the eyes. In case of eye contact, immediately flush with water. Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any ingredients
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