Puroma Instant Foaming Hand Sanitizer Without Fragrance
FDA Label NDC 80948-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zenith Micro Control for the product Puroma Instant Foaming Hand Sanitizer Without Fragrance (NDC 80948-012). 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 drug facts, active ingredient, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol 75% V/V
Purpose
Antimicrobial.
Uses
Hand Sanitizer to help reduce bacteria on skin.
Recommended for repeated use.
Warnings
Flammable. Keep away from fire or flame.
For external use only.
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.
Inactive Ingredients
Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate, PEG-12 Dimethicone (300 CST)
Other Information
Store below 110°F (43°C).
May discolor certain fabrics or surfaces.
Product Label
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