Active Ingredient
Benzalkonium chloride 0.13% w/w
Sanitary Wet Wipes
FDA Label NDC 81306-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dandong Xinshidai Biotec Pharmaceuticals Co.,ltd for the product Sanitary Wet Wipes (NDC 81306-001). 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 active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
Suitable for wiping hands, face, skin and other unbroken skin.
Warnings
For external use only.
When using this product avoid to contact eyes, wounds and other sensitive parts. 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.
This product is insoluble in water, please put it in the trash after use.
Otc - When Using
When using this product avoid to contact eyes, wounds and other sensitive parts. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
Directions
Take out the wet wipes and use directly
Other Information
· Store in a cool place, avoid sunlight or high temperature.
· Shelf Life: 2 years
· Product specification: 160mm × 200mm
· Product features: pure cotton texture, soft and comfortable
It has bactericidal effect on Staphylococcus aureus, Escherichia coli and Candida albicans.
· See the code on the package for the expiration date and production lot number
Inactive Ingredients
RO water, Bronopol
Package Label.Principal Display Panel
Net Contents: 1 PCS; NDC: 81306-001-01
1pcs Label (Label 1pcs)
Net Contents: 10PCS; NDC: 81306-001-02
10pcs Label (Label 10pcs)
Net Contents: 60PCS; NDC: 81306-001-03
60pcs Label (Label 60pcs)
Net Contents: 72PCS; NDC: 81306-001-04
72pcs Label (Label 72pcs)
Net Contents: 80PCS; NDC: 81306-001-05
80pcs Label (Label 80pcs)
Net Contents: 100PCS; NDC: 81306-001-06
100pcs Label (Label 100pcs)
* Please review the disclaimer below.
