Otc - Active Ingredient
Active Ingredient
Ethanol 65%
Hand Sanitizer Gel
FDA Label NDC 65692-1002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc. for the product Hand Sanitizer (NDC 65692-1002). 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, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Warnings
Warnings
Flammable, keep away from fire or flame.
For external use only.
Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention.
Otc - Stop Use
Stop use and ask doctor if irritation and redness develops and persists for more than 72 hours.
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
Directions
- Dispense an adequate amount in your palm to cover all surfaces of hands completely.
- Rub hands together until dry.
- Does not require rinsing.
Inactive Ingredient
Inactive Ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Triethanolamine.
Indications & Usage
Uses
- For handwashing to decrease bacteria on the skin.
- Recommended for repeated use.
Other Information
- Do not store above 105 F
- May discolor some fabrics.
Package Label.Principal Display Panel
Image Of Bottle Label (Label)
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