Otc - Active Ingredient
Active Ingredient
Benzalkonium Chloride 0.1%
Foamfresh Alco-free Hand Sanitizer Liquid
FDA Label NDC 11429-1001
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-free Hand Sanitizer (NDC 11429-1001). 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.
Recommended for repeated use.
Warnings
Warnings:
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 conditions persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Children must be supervised in use of this product.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
Pump a small amount of foam into palm of hand.
Rub thoroughly over all surfaces of both hands.
Rub hands together briskly until dry.
Inactive Ingredient
Inactive Ingredients:
Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance.
Package Label.Principal Display Panel
FoamFresh
Alco-Free Hand Sanitizer
Formulated to reduce the number of germs on the hands that can cause infection and illness
Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere
Use on clean, non-soiled hands any time when rinsing with water is not available
Kills 99.99% of common germs that can cause disease
PK
Woodbine Products Company
915 West Smith Road
Medina, Ohio 44256
wwww.woodbineproducts.com
Made in the U.S.A.
Stock # 4350 1000 ml (34 fl. oz.)
* Please review the disclaimer below.
