Active Ingredients
Active Ingredient[s]/ Purpose
Alcohol 80% v/v..........Antiseptic
Nelsons Green Brier Hand Sanitizer
FDA Label NDC 74204-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nelson's Green Brier Distillery, Llc for the product Nelsons Green Brier Hand Sanitizer (NDC 74204-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, do not use, purpose:, stop use, when using, other information, warnings and precautions, inacative ingredients section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
