Active Ingredient
Ethyl Alcohol 70.0% v/v
Naked X Restore Hand Sanitizer
FDA Label NDC 79116-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Essations Inc. for the product Naked X Restore Hand Sanitizer (NDC 79116-000). 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 ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Uses
• For handwashing to decrease bacteria on the skin. • Moisturinzing, cleansing solution. • Repeated use encouraged.
Warnings
For external use only.
Flammable; keep away from heat, fire, and flame.
Avoid contact with eyes, ears, and mouth. In case of eye contact, flush thoroughly with water for 10 minutes.
Stop Use And Ask A Doctor If
irritation and redness develop and persist for more than 72 hours.
Keep Out Of Reach Of Children.
If swallowed, immediately seek medical attention or contact poison control.
Directions
• Apply a generous amount to one palm. • Rub to saturate both palms. • Rub across back of hands, between fingers, & around thumbs covering all surafces until they feel dry.
Other Information
• Store at 20°C to 25°C (68°F to 77°F)
• May discolor certain surfaces and fabrics.
Inactive Ingredients
D.I. Water (Aqua), Polysorbate-20, Fragrance, Carbomer, Triethanolamine.
Package Labeling:64Ml
Label (Label)
Package Labeling:946Ml
Label2 (Label2)
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