Otc - Active Ingredient
Alcohol 70% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 75078-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scentsational Soaps & Candles, Inc. for the product Hand Sanitizer (NDC 75078-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic, Hand Sanitizer
Indications & Usage
Hand Sanitizer to help reduce bacteria that potentially can cause a disease. For use when soap and water is not available.
Warnings
For extrenal use only. Flammable. Keep away from heat or flame.
Otc - Do Not Use
* In children in less than 2 months of age
* on open skin wounds
Otc - When Using
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 irritationor rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
Dosage & Administration
* 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.
Storage And Handling
* Store between 15-30C (59-86F)
* Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
purified water USP, glycerin, Aloe barbadensis Leaf Juice, Hydrogen Peroxide
Package Label.Principal Display Panel
100.55 mL NDC: 75078-002-01
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