Otc - Active Ingredient
Active Ingredient
Ethyl Alcohol 62% v/v
Foamfresh Alco-foam Hand Sanitizer Liquid
FDA Label NDC 11429-1004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Woodbine Products Company for the product Foamfresh Alco-foam Hand Sanitizer (NDC 11429-1004). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antimicrobial
Indications & Usage
Uses:
For hand sanitizing to decrease bacteria on the skin that could cause disease.
Recommended for repeated use.
Warnings
Warnings:
Flammable. Keep away from fire or flame
For external use only
Otc - When Using
When using this product avoid contact with eyes.
In case of eye contact, flush eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops, or if condition 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:
Place enough product in your palm to thoroughly cover your hands.
Rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.
Storage And Handling
Other information:
Store below 110 F (43 C).
May discolor certain fabrics or surfaces.
Inactive Ingredient
Inactive ingredients:
Water, DEA-C8-18 Perfluoroalkylethyl Phosphate
Package Label.Principal Display Panel
Alco-Foam
Hand Sanitizer
Decreases common germs that
can cause illness. Leaves skin
soft and refreshed.
Woodbine Products Company
915 West Smith Road
Medina, Ohio 44256
www.woodbineproducts.com
Made in the USA
Stock # 4640 900 ml (31 fl. oz.)
FoamFresh Alco-Foam
Sanitizer
* Please review the disclaimer below.
