Otc - Active Ingredient
Ethyl Alcohol 70%
Hydrating Hand Saintizer
FDA Label NDC 80382-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natural Distributions Ltd. O/a Purple Frog Products Suite for the product Hydrating Hand Saintizer (NDC 80382-001). 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 - keep out of reach of children, user safety warnings, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose -Antiseptic Skin cleanserÂ
Indications & Usage
Use
- Antiseptic Skin cleanser
Warnings
Warnings
Keep away from open flame & sources of heat.
For extenal use only.
Otc - Keep Out Of Reach Of Children
Keep out of children
If accidently swallowed, call a posion control center or get medical help right away.
User Safety Warnings
Do not get into eyes
If contact occurs, rinse thoroughly with water
Dosage & Administration
- Children,adolescents and adults 2 years and over.
- for occasional and personal domestic use
- supervise children when they use this product.
- Place enough product on your plam to thoroughly cover your hands.
- rub thoroughly into hands for at least 30 seconds
- Allow to dry.
Other Safety Information
Other Information
- May discolor certain fabrics or surfaces
- do not store above 110 F ( 43 C)
Inactive Ingredient
Distilled Water, Vegetable Glycerin, PEG 10 Dimethicone, Grapefruit Essential Oil Blend, Aloe Barbadensis Leaf Juice, Denatonium Benzoate.
Package Label.Principal Display Panel
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