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Drug Facts
Seren Guard
FDA Label NDC 79183-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Pace Products Llc for the product Seren Guard (NDC 79183-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Benzalkonium Chloride 0.13%
Otc - Purpose
Purpose
Antimicrobial
Indications & Usage
Uses ■ Hand Sanitizer to decrease bacteria on skin.
■ Recommended for repeated use.
Warnings
Warnings
For external use only.
Otc - When Using
When using this product keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Discontinue use if irritation and redness develop. If the condition
persists for more than 72 hours, consult a Physician.
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.
Dosage & Administration
Directions ■ Thoroughly wipe hands as desired.
■ Allow to dry without wiping.
■ Discard wipe after use.
■ Do not flush.
Storage And Handling
Other Information
■ Keep sealed and store between 0-30°C (32 - 86°F)
■ For External Use Only. Avoid sun exposure and excessive heat above 40°C
Inactive Ingredients
Inactive Ingredients
Aqua, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20,
Phenoxyethanol.
Package Label - Principal Display Panel
SEREN GUARD 80
WIPES
Alcohol Free Skin friendly Ingredients
SEREN GUARD 80
WIPES
Sanitizing Wipes
STERILIZATION RATE 99.9%
USAGE
Click open the lid and peel back the resealable label.
Pull a sterilized wipe for sanitizing hands.
Reseal label after use to prevent the wipes from drying.
Batch No: Printed on bag.
Distributed By: Prime Pace Products LLC, 36181 East Lake Rd, Suite 302, Palm Harbor, FL 34685, USA
Toll Free Number: 866-518-1984
Email: [email protected]
ITEM CODE: SGNA-02
6 970366 697128
Made in China
res
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