The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Hand sanitizer to help reduce bacteria that potenially can cause disease. For use when soap and water are not available.
For external use only. Flammable. Keep away from heat or flame
Do Not Use
• in children less than 2 months of age• on open skin wounds
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
• Place enough product on hands to cover all surfaces. Rub hands together until dry.• Supervise children under 6 years of age when using this product to avoid swallowing.
• Store between 15-30C (59-86F)• Avoid freezing and excessive heat above 40C (104F)
Recent Major Changes
Note: Recent Major Changes (§ 201.57(a)(5))
When substantive labeling changes have been made to any of the following sections of the FPI within the preceding 12 months, the heading(s) of the changed section(s) must be listed in Highlights under the heading Recent Major Changes (§ 201.57(a)(5)):
• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Warnings and Precautions
Changes that must not be listed in Recent Major Changes include:
• Changes to sections other than the five listed above
• Changes that are not substantive (i.e., minor revisions such as correcting typographical errors or grammatical changes)
• Changes resulting from converting to the PLR format alone
a. What must be included ?
Each listing must include the section heading, the subsection heading (if appropriate), identifying number of the corresponding changed section or subsection, and the date on which the change was incorporated in the labeling (i.e., date the supplement was approved) in month/year format (e.g., 6/2010 or Jun 2010) (§ 201.57(a)(5)).
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