Otc - Active Ingredient
Active ingredient
Benzalkonium Chloride 0.13%
Protect 8
FDA Label NDC 63002-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Hygienics Llc for the product Protect 8 (NDC 63002-003). 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 condition persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Pump a small amount of foam onto hands.
Rub thoroughly over all surfaces of both hands.
Rub hands together briskly until dry.
Inactive Ingredient
Inactive ingredients
Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric acid.
Package Label.Principal Display Panel
PROTECT 8
Long Lasting
Germ Guard
Kills and Protects
16.9 FL OZ (500mL)
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