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Safehands - Medication Information

Product NDC Code 60867-102
Drug Name

Safehands

Type Brand
Active Ingredients
Benzalkonium chloride .13 g/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1049254
Application Number part333A
Labeler Name safeHands Distribution Ne, LLC
Packages
Package NDC Code Description
60867-102-02 52 ml in 1 bottle (60867-102-02)
60867-102-07 208 ml in 1 bottle (60867-102-07)
60867-102-18 532 ml in 1 bottle (60867-102-18)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Benzalkonium chloride, 0.13%

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 Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of this product.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate 20, Fragrance, FD&C Blue No. 1

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 To decrease bacteria on the skin.

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic hand sanitizer

Spl product data elements

Usually a list of ingredients in a drug product.
safeHands Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM Water COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE PROPYLENE GLYCOL TRIETHYLENE GLYCOL POLYSORBATE 20 FD&C BLUE NO. 1

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.
safeHands® Alcohol Free Hand Sanitizer Kills 99.9% of germs. • Non-toxic • Moisturizing Clean Linen 20140927 Safehands 102

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.
Other Information Avoid extreme temperatures. Questions/Comments? Call toll free 888-338-1338 safeHands® Next Generation Hand Sanitizer Kills 99.9% of germs while pampering your hands Learn more at: www.safehands.com A percentage of profits is donated to Safe Kids Worldwide to “keep all kids safe from preventable injuries” #1 Alcohol Free Brand Manufactured for safeHands, LLC, Boca Raton, FL Patent Pending 61/473 385 Made in the USA

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 eyes. In case of contact, rinse eyes thoroughly with water.

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 skin irritation develops.

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 eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if skin irritation develops.

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