FDA Label for Steral Antiseptic Sanitizing Wipe

View Indications, Usage & Precautions

Steral Antiseptic Sanitizing Wipe Product Label

The following document was submitted to the FDA by the labeler of this product Steral Products Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




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




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