Steral Antiseptic Sanitizing Wipe
FDA Label NDC 82045-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Steral Products Limited for the product Steral Antiseptic Sanitizing Wipe (NDC 82045-050). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzalkonium chloride 0.075% w/v
Purpose
Antiseptic
Uses
• hand sanitizing wipe to decrease bacteria on skin • for use when soap and water are not available
Warnings
For external use only.
Do not use • in children less than 2 months of age • on open skin wounds
When using this product • do not get into eyes.
In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if • irritation and redness develop • condition persist for more than 72 hours • there are symptoms of serious allergic reactions.
Contains chlorhexidine digluconate.
If pregnant or breast-feeding, ask a health professional before use.
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
• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing • discard after use • do not dispose of wipes in flush toilet
Other Information
• store between 15-30°C (59-86°F)
Inactive Ingredients
Chlorhexidine Digluconate, Didecyldimethylammonium Chloride, Ethyl Alcohol, Lauramine Oxide, p-Chloro-m-Cresol, Propylene Glycol, Water (Aqua)
Questions?
+1-XXX-XXX-XXXX
You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM
Packaging
Hand Sanitizer (82045 050 01 03)
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