Otc - Active Ingredient
Active Ingredient
Ethyl Alcohol 70% v/v
Alco Hand Sanitizer Gel
FDA Label NDC 11429-1003
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 Alco Hand Sanitizer (NDC 11429-1003). 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
Sanitizer
Indications & Usage
Uses:
For hand sanitizing to decrease bacteria on the skin.
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:
Apply gel to dry hands and rub thoroughly until hands are dry.
Do not rinse or wipe gel off.
Should solution enter eyes, rinse immediately with water.
Storage And Handling
Other Information:
Store below 110 F (43 C).
May discolor certain fabrics or surfaces.
Inactive Ingredient
Inactive Ingredients:
Water, Propylene Glycol, PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Triethanolamine, Carbopol and Fragrance.
Package Label.Principal Display Panel
Alco-Gel Hand Sanitizer
Evaporates quickly
Kills 99.99% of common germs that can cause illness
Leaves hands smooth and refreshed
PK
Woodbine Products Company
915 West Smith Road
Medina, Ohio 44256
www.woodbineproducts.com
Made in the U.S.A.
Stock # 4330 10000 ml (34 fl. oz.)
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