Otc - Active Ingredient
Active Ingredient
Benzalkonium Chloride 0.13% w/w
Sipa Hand Sanitizing Wipes Cloth
FDA Label NDC 85137-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sipa Holdings Usa, Inc. for the product Sipa Hand Sanitizing Wipes (NDC 85137-001). 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
Antiseptic
Indications & Usage
Use
For hands sanitizing to decrease bacteria on the skin. Recommended for repeated use.
Warnings
Warnings
For external use only.
Otc - When Using
When using this product do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
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
· Wet hands thoroughly with product and allow to dry.
· Discard wipes in trash receptacle after use. Do not flush.
· Children under 6 years of age should be supervised when using this product.
Inactive Ingredient
Inactive Ingredients
Water, Glycerin, Aloe Barbadensis Leaf Juice, Decyl Glucoside, Phenoxyethanol, Fragrance.
Package Label.Principal Display Panel
50PCS
NDC: 85137-001-01
100 WIPES
NDC: 85137-001-02
250PCS
NDC: 85137-001-03
500PCS
NDC: 85137-001-04
* Please review the disclaimer below.
