FDA Label for Nelsons Green Brier Hand Sanitizer
View Indications, Usage & Precautions
Nelsons Green Brier Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Nelson's Green Brier Distillery, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Active Ingredient[s]/ Purpose
Alcohol 80% v/v..........Antiseptic
Do Not Use
Do not use
- in children less than 2 months of age
- on open skin wounds
Purpose:
Use[s]
Hand Sanitizer to help reduce bacteria potentially can cause disease. For use when soap and water are not available.
Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
When Using
When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Other Information
Other Information
- Store between 15- 30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Warnings And Precautions
Warnings
For external use only. Flammable. Keep away from heat or flame.
Inacative Ingredients Section
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
Dosage And Administration
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years when using this product to avoid swallowing.
Warning
For external use only. Flammable. Keep away from heat or flame
Indications & Usage Section
Hand Sanitizer to help reduce bacteria potentially can cause disease. For use when soap and water are not available.
Keep Out Of Reach
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Recent Major Changes Section
N/A Original Label
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
• Contraindications
• 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)).
Primary Display Panel
Nelson's
Green Brier
Distillery
Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-sterile Solution
118.3mL
Not for Resale
Not for Consumption
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