Storage And Handling
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Hand Sanitizer
FDA Label NDC 73995-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Barley Creek Associates, L.p. for the product Hand Sanitizer (NDC 73995-100). 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 storage and handling, description, general precautions, inactive ingredient, otc - purpose, otc - active ingredient, otc - keep out of reach of children, use in specific populations, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
Directions
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.
General Precautions
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
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may me signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
Otc - Purpose
Purpose - Antiseptic
Use(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Otc - Active Ingredient
Active ingredient(s) - Alcohol 80% v/v
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Use In Specific Populations
Do not use
In children less than 2 months of age
On open skin wounds
Dosage & Administration
Directions
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.
Indications & Usage
Use(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Warnings
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
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may me signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
Drug Facts (Drugfactslabel)
Alcohol Antiseptic 80% (1102barleycreekaats80)
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