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| Product NDC Code | 68776-1007 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Afco 5515 hand sanitizer |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | LOTION | ||||||||||||
| Application Number | M007 | ||||||||||||
| Labeler Name | Acuity Specialty Products, Inc dba AFCO US | ||||||||||||
| 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 Ingredients : lsopropyl Alcohol 75%
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: • Place a palmful of product in one hand • Spread on both hands and rub into the skin until dry (1-2 min.) • No rinsing or toweling required
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, glycerin
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• Helps prevent cross contamination by hand contact • Helps prevent drying and chafing of skin • Recommended for repeat 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.AFCO 5515 Hand Sanitizer ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER GLYCERIN
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.Product Package AFCO 5515 Hand Sanitizer TDG: LIMITED QUANTITY MANUFACTURED BY: Alex C. Fergusson, LLC 800 DEVELOPMENT AVENUE CHAMBERSBURG, PA 17201 TOLL FREE: 800-345-1329 NDC# 68776-1007-4 BATCH NO.: EXP. DATE: 00/00/2000 CONTENTS: 6 x 1000 mL CHEMTREC EMERGENCY 800-424-9300 (Chemtrec Customer Number: CCN837) HMIS HAZARD RATING HEALTH 1 FLAMMABILITY 3 REACTIVITY 0 PERSONAL PROTECTION A CHEMTREC EMERGENCY 800-424-9300 (Chemtrec Customer Number: CCN837) 1000 mL Cartridge Label 6 x 1000 mL Box Label res 1007-4 Cartridge 1007-4 6x1000mL
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
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. In case of accidental ingestion, seek medical attention or contact poison control center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Flammable, keep away from fire or flame.
Other Information: Store in a cool dry place below 104°F • Recommended for use in AFCO Systems • For Food Processing, Food Service and Professional Use Only
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: For product or technical information, contact AFCO Monday to Friday 8 AM to 4 PM EST at 1-800-345-1329 or visit our website at www.afcocare.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 persists for more than 72 hours.
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 use in or near eyes. Discontinue use if irritation or redness develops. Use in well-ventilted area.
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
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