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Drug Facts
Seren Guard
FDA Label NDC 79183-501
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 79183-501). 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 Ingredients
Ethyl Alcohol 75%
Otc - Purpose
Purpose
Antiseptic
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 below 95°F (35°C)
■ Avoid sun exposure and excessive heat above 104°F (40°C)
Inactive Ingredients
Purified Water, Glycerin, Aloe Barbadensis Extract,
Phenoxyethanol, Ethylhexylglycerin, Propylene Glycol.
Package Label - Principal Display Panel
80
COUNT
SEREN GUARD
Sanitizing Wipes
KILLS 99.9% OF KNOWN GERMS
SANITIZING WIPES WITH SKIN FRIENDLY INGREDIENTS
75% Alcohol - Multi Purpose
Cleansing Formula
Antiseptic
These germ fighting sanitizing wipes kill 99.9% of known germs.
Made with skin friendly ingredients, using no harsh chemicals.
Contains 75% Ethyl Alcohol to kill germs and sanitize hands.
Contains Glycerin to lock in moisture and soften the skin.
Batch No: Printed on side.
Distributed By: Prime Pace Products LLC, 36181 East Lake Rd,
Suite 302, Palm Harbor, FL 34685, USA
Toll Free Number: 877-826-9371
Email: [email protected]
FOR: UBOXES LLC
MATERIAL: NON-WOVEN
WIPES SIZE: 15X20CM
WIPES: 80 SHEET COUNT
ITEM CODE : SGAL-06
0 5 0 6 6 2 0 2 0 0 6 9
Made in China
80 Wipes
Icolor2 (Icolor2)
res
* Please review the disclaimer below.
