BIOPURE 50CT ANTI BACTERIAL HAND WIPES
79794-800
ee484505-3bb1-2989-e053-2995a90aea2b
HUMAN OTC DRUG LABEL
Sep 30, 2025
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
DUNS: 723796509
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzalkonium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Label 79794-800-11
INDICATIONS & USAGE SECTION
Uses
●Hand sanitizer to help reduce bacteria
●For use when soap and water not available.
WARNINGS SECTION
Warnings
For external use only.
Do not use
●in children less than 2 months old.
●on open skin wounds
When using this product
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor
if irritation or rash occurs.
These may be signs of a serious condition
Keep out of reach of children.
If swallowed. get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
●Apply to hands, allow to air dry without wiping.
●Children under 6 years of age should be supervised when using this product
STORAGE AND HANDLING SECTION
Other Information
●Store in a cool, dry place.
●Avoid freezing and excessive heat.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Aloe Barbadensis Leaf Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water
POSTMARKETING EXPERIENCE SECTION
Question?
Call 718-975-2586
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Benzalkonium Chloride 0.13%
OTC - PURPOSE SECTION
Purpose
Antibacterial